Cold & Immunity Kit

Medication Information Guide

General Disclaimer:These medications should always be used responsibly and after consultation with a qualified healthcare professional or primary care provider for diagnosis and treatment instructions before utilizing any medications in your kit. If you have any questions, Amble offers a team of licensed medical professionals to help.

Storage Information

Most solid oral drugs have a longer shelf life when stored at room temperature (68–77°F / 20–25°C) and shielded from UV radiation in airtight containers. The FDA's Shelf-Life Extension Program showed that many solid form medications stayed potent beyond their expiration date.

Amoxicillin-Clavulanate 875 mg/125 mg

(generic Augmentin™)

Pharmacologic Category: Antibiotic, Penicillin

FDA-Approved Uses:

• Lymphadenitis (lymph node inflammation)
• Mastitis (breast tissue inflammation)
• Otitis Media (inner ear infection)
• Acute Pharyngitis, Group A streptococcus (strep throat)
• Tonsilitis (tonsil inflammation)
• Urinary tract infection (UTI)

Common Off-Label Uses:

• Acute bacterial rhinosinusitis (nasal passage & sinus infection)
• Lung abscess
• Empyema
• Pyomyositis (bacterial infection of skeletal muscle)
• Bite wound (human, dog, cat)
• Dental infections
• Community-acquired pneumonia, mild
• Diabetic foot infection
• Chronic obstructive pulmonary disease (COPD), acute exacerbation

Typical Adult Dosing:

Community-acquired pneumonia, mild:Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 5-10 days*Can be used in combination with Azithromycin or Doxycycline

Bite wounds (human, dog, cat), prophylaxis (asymptomatic exposure):Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 3-5 days

Bite wounds (human, dog, cat), treatment (symptomatic infection):Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 7-14 days

Urinary Tract Infection (UTI), uncomplicated:Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 3-7 days

Acute bacterial rhinosinusitis (nasal passage & sinus infection):Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 5-7 days

Acute pharyngitis, group A streptococcus (strep throat):Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 10 days

Pregnancy: Pregnancy Risk Category B (see Appendix A). Consult with a medical provider.

Breastfeeding: Present in breastmilk, considered compatible with breastfeeding when used in usual recommended doses.

Notes: While Amoxicillin-Clavulanate may be taken with food or on an empty stomach, the risk of gastrointestinal side effects is decreased when taken with meals.

Common Side Effects: Gastrointestinal including diarrhea nausea, vomiting, and rash.

Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Amoxicillin, clavulanic acid, or other beta-lactam antibacterial drugs (e.g. PENICILLINS, CEPHALOSPORINS) or any other component of the formulation. DO NOT TAKE if history of cholestatic jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy. Avoid use in suspected or confirmed mononucleosis infection.

Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection. Please review the full package insert and consult with a medical provider for additional information.

Azithromycin 250 mg

(generic Zithromax™, Z-Pak™)

Pharmacologic Category: Antibiotic, Macrolide

FDA-Approved Uses:

• Community-acquired pneumonia, mild severity
• Acute Pharyngitis, Group A streptococcus (strep throat)
• Acute bacterial sinusitis (sinus infection)
• Acute otitis media (inner ear infection)
• Acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD)
• Uncomplicated skin infections
• Urethritis and cervicitis (caused by Chlamydia trachomatis)

Common Off-Label Uses:

• Babesiosis (malaria-like parasitic disease)
• Bartonella (cat scratch disease)
• Infectious traveler's diarrhea
• Pertussis (whooping cough)
• Bronchiectasis

Typical Adult Dosing:

Community-acquired pneumonia, mild severity:Take Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2-5orTake Azithromycin 500 mg (2 tablets) by mouth DAILY for 3 days

Infectious traveler's diarrhea:Take Azithromycin 500 mg (2 tablets) by mouth DAILY for 3 days

Viral upper respiratory infection, Bronchitis, Pertussis:Take Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2-5

Sexual transmitted infection (STI), chlamydia:Take Azithromycin 1,000 mg (4 tablets) by mouth ONE TIME, repeat after 1 week if needed

Acute bacterial pharyngitis, Sinusitis, Tonsillitis:Take Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2-5

Babesiosis, Bartonella:Take Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2-5

Pregnancy: Pregnancy Risk Category B (see Appendix A).

Breastfeeding: Present in breastmilk, use caution. Consult with a medical provider.

Notes: While Azithromycin may be taken with food or on an empty stomach, the risk of gastrointestinal side effects is decreased when taken with meals.

Common Side Effects: Gastrointestinal including diarrhea and nausea.

Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Azithromycin (Zithromax™, Z-Pak™), Clarithromycin (Biaxin™), Erythromycin (Erythrocin™, Ery-Tab™, or E.E.S.™), or any other Macrolide. DO NOT TAKE if history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use. Azithromycin is listed as a contraindication in the manufacturer's labeling for pimozide.

Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Azithromycin may affect the efficacy of blood thinners, like warfarin, which could increase the risk of bleeding. Medical supervision may be necessary to monitor clotting times and, if necessary, adjust the dosage of anticoagulants during Azithromycin treatment. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection. Please review the full package insert and consult with a medical provider for additional information.

Ondansetron 4 mg

(generic Zofran™)

Pharmacologic Category: Antiemetic; Selective 5-HT3 Receptor Antagonist

FDA-Approved Uses:

• Cancer chemotherapy-induced nausea and/or vomiting
• Postoperative nausea and/or vomiting
• Radiotherapy-associated nausea and/or vomiting

Common Off-Label Uses:

• Nausea and/or vomiting, acute, severe
• Pregnancy-associated nausea and/or vomiting
• Vertigo-associated nausea and/or vomiting

Typical Adult Dosing:

Nausea and/or vomiting, acute, severe:Take Ondansetron 4 mg (1 tablet) by mouth EVERY 4 to 8 HOURS, as needed for nausea or vomiting**Do not exceed 16 mg (4 tablets) in a 24-hour period

Pregnancy: Pregnancy Risk Category B (see Appendix A). Consult with a medical provider.

Breastfeeding: Presence in human breast milk is unknown. Potential harm to breastfeeding infants is unknown. Consult with a medical provider.

Notes: Ondansetron may be taken with food or on an empty stomach. Take with a full glass of water.

Common Side Effects: Headache, constipation, diarrhea, dizziness, drowsiness, fatigue, and malaise.

Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Ondansetron (Zofran™), or any other component of the formulation; DO NOT TAKE with apomorphine.

Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Additional considerations in persons taking other serotonergic agents (e.g. SSRIs, SNRIs, MAOIs) or with a history of Serotonin syndrome. May cause dizziness/drowsiness, advise caution while driving. Please review the full package insert and consult with a medical provider for additional information.

Methylprednisolone DP

(generic Medrol™ Dosepak™)

Pharmacologic Category: Corticosteroid; glucocorticoid

FDA-Approved Uses:

• Allergic states
• Dermatologic diseases
• Endocrine disorders
• Gastrointestinal diseases
• Hematologic disorders
• Neoplastic diseases
• Nervous system conditions
• Ophthalmic diseases
• Renal diseases
• Respiratory diseases
• Rheumatic disorders

Common Off-Label Uses:

• Acute asthma or COPD exacerbation
• Acute musculoskeletal inflammation
• Acute gout flare
• Severe allergic reactions, adjunctive treatment
• Radiculopathy or sciatica-associated inflammation
• Sinus or upper respiratory inflammation

Typical Adult Dosing:

Take Methylprednisolone as directed on the dose pack, usually over 6 days with a tapering schedule. Follow the package instructions or medical provider instructions exactly.

Inflammatory or allergic conditions:Dosing varies widely based on condition, severity, response, and treatment duration; use only as directed by a medical provider

Pain:Only for low back WITH moderate/severe radicular pain: Follow directions per medication label

Moderate Allergy/Hives/Angioedema:Cetirizine: 10mg by mouth 1 time per day. May increase to 2 times per day if neededORCetirizine: 10mg by mouth 1 time in the morning, plus diphenhydramine 25-50 mg by mouth at bedtimeIf symptoms still present then add, Famotidine: 20mg by mouth every 12 hoursIf symptoms still present then add a corticosteroid, Methylprednisolone: follow directions per medication label

Pregnancy: Pregnancy Risk Category C (see Appendix A)

Breastfeeding: Discuss with your doctor if the benefits of taking this medication outweigh the risks.

Notes: Due to concern with Torsades de pointes (heart rhythm disturbance), cardiac arrest, and death, do not use higher than recommended doses of loperamide and avoid it in children under age 2.

Common Side Effects: Serious side effects (mostly due to long term use) include adrenal suppression, apathy, depression, psychiatric disturbances (including agitation, anxiety, mood changes, restlessness, and tearfulness), Cushing's syndrome, peptic ulcer, abdominal distention, hyperglycemia, diabetes, infection, osteoporosis, muscle problems, or glaucoma. Less common side effects include: low heart rate, heart rate abnormalities, swelling, heart failure, high blood pressure, heart rupture (after recent heart attack), fainting, tachycardia, acne, allergic dermatitis, bruising, dry skin, decreased serum potassium, weight gain, hiccups, increased appetite, nausea, anaphylaxis, angioedema, non-immune anaphylaxis, euphoria, headache, neuropathy, paresthesia, personality changes, seizure, vertigo, tendon rupture, impaired wound healing.

Contraindications: Allergy or hypersensitivity to methylprednisolone or any component of formulation. Current systemic fungal infection. Co-administration with live or attenuated virus vaccines. History of immune thrombocytopenia, or idiopathic thrombocytopenic purpura. Administration to premature infants.

Caution: Caution with diabetes, high blood pressure, heart disease, kidney disease, liver disease, stomach ulcers, glaucoma, cataracts, osteoporosis, thyroid disease, seizure disorder, mood disorders, or history of infection. Caution with NSAIDs, blood thinners, diabetes medications, certain vaccines, CYP3A4 inhibitors or inducers, and other immunosuppressive medications. May mask signs of infection or worsen existing infections. Seek medical attention for severe mood changes, vision changes, black or bloody stools, severe abdominal pain, signs of infection, swelling, shortness of breath, or symptoms of high blood sugar.

Cetirizine

(generic Zyrtec™)

Pharmacologic Category: Antihistamine

FDA-Approved Uses:

• Allergic Rhinitis or Conjunctivitis

Common Off-Label Uses:

• Allergic Reaction
• Angioedema
• Hives

Typical Adult Dosing:

Allergic Rhinitis or Conjunctivitis:1 pill by mouth once daily as needed

Mild to Moderate Allergic Reaction, Angioedema, Hives:Cetirizine: 10 mg by mouth 1 time per day. May increase to 2 times per day if neededORCetirizine: 10 mg by mouth 1 time in the morning, plus diphenhydramine 25-50 mg by mouth at bedtimeIf symptoms still present then add, Famotidine: 20 mg by mouth every 12 hoursIf symptoms still present then add a corticosteroid, Methylprednisolone: follow directions per medication label

Pregnancy: Pregnancy Risk Category B (see Appendix A)

Breastfeeding: Discuss with your doctor if the benefits of taking this medication outweigh the risks.

Notes: Cetirizine may cause drowsiness, although it is generally considered less sedating than first-generation antihistamines. Avoid alcoholic drinks while taking cetirizine. Alcohol, sedatives, and tranquilizers may increase drowsiness. Use caution when driving a motor vehicle or operating machinery. Ask a medical provider before use if you have liver or kidney disease, as a different dose may be needed.

Common Side Effects: Serious side effects include sedation, fatigue, and psychosis. Other side effects include: drowsiness, headache, abdominal pain, diarrhea, vomiting, dry mouth, dizziness, bronchospasm, chest pain, skin changes, weight gain, heavy menstrual bleeding, urinary frequency, joint pain, visual changes, hearing changes, etc.

Contraindications: Allergy or hypersensitivity to cetirizine, hydroxyzine, levocetirizine, or any component of formulation. Allergy or hypersensitivity to piperazine derivatives. History of severe kidney impairment.

Caution: Caution with alcohol, sedatives, tranquilizers, sleep medications, opioids, benzodiazepines, or other medications that may cause drowsiness. Caution in patients with kidney disease, liver disease, urinary retention, enlarged prostate, or elderly patients due to possible increased risk of side effects. Stop use and seek medical help right away if an allergic reaction occurs. Do not exceed the recommended dose unless directed by a medical provider.

Acetaminophen

(generic Tylenol)

Pharmacologic Category: Antipyretic, analgesic

FDA-Approved Uses:

• Pain
• Fever

Common Off-Label Uses:

• Fever
• Pain
• Muscle/Joint Pain

Typical Adult Dosing:

Fever:325-650 mg by mouth every 4-6 hours as needed. Do not exceed 4000 mg per day.

Pain (Dysmenorrhea, low back pain, acute migraines, osteoarthritis, etc.):325-650 mg by mouth every 4-6 hours as needed. Do not exceed 4000 mg per day.

Pregnancy: Pregnancy Risk Category B (see Appendix A)

Breastfeeding: Considered compatible with breastfeeding

Notes: Acetaminophen is used for temporary relief of minor aches, pains, and fever. Check all prescription and over-the-counter medication labels before use, as acetaminophen is commonly included in combination products, including cold/flu medications and some pain medications. Do not exceed the recommended daily dose. Taking more than directed may cause serious liver injury. Avoid or limit alcohol use while taking acetaminophen due to increased risk of liver injury. Use only as directed by the product label or a medical provider.

Common Side Effects: Serious side effects include acute liver toxicity (usually only in people who exceed 4 grams per day). Less common side effects include skin rash, skin blisters, and hearing loss.

Contraindications: Do not take if you have an allergy or hypersensitivity to acetaminophen or any component of formulation, or a history of severe hepatic impairment.

Caution: Caution in patients with liver disease, heavy alcohol use, chronic malnutrition, or history of significant alcohol intake. Caution with concurrent use of other medications containing acetaminophen to avoid accidental overdose. Caution with warfarin or other blood thinners, especially with regular or prolonged acetaminophen use. Stop use and consult a medical provider if pain worsens or lasts more than 10 days, fever worsens or lasts more than 3 days, new symptoms occur, or redness/swelling is present. Seek immediate medical attention in case of overdose, even if there are no symptoms.

Ibuprofen

(generic Advil™, Motrin™)

Pharmacologic Category: Non-steroidal anti-inflammatory drug

FDA-Approved Uses:

• Temporary relief of minor aches and pains
• Temporary reduction of fever
• Relief of mild to moderate pain
• Treatment of primary dysmenorrhea
• Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, depending on formulation

Common Off-Label Uses:

• Gout Flare
• Musculoskeletal pain
• Back pain
• Dental pain
• Headache
• Postoperative pain
• Inflammatory pain when directed by a medical provider

Typical Adult Dosing:

Fever:200-400 mg by mouth every 4-6 hours as needed. If fever persists, may increase to 600-800 mg by mouth every 6 hours as needed. Do not exceed 3200 mg per day.

Gout Flare:800 mg by mouth every 8 hours until symptoms improve. Do not exceed 3200 mg per day.

Pain (Dysmenorrhea, low back pain, acute migraine, osteoarthritis, etc.):200-400 mg by mouth every 4-6 hours as needed. Do not exceed 3200 mg per day.

Pregnancy: Pregnancy Risk Category B in first and second trimesters. Pregnancy Risk Category D in the third trimester.

Breastfeeding: NSAIDs are generally considered safe short term except if infant has low platelet count or other platelet dysfunction, or certain cardiac conditions.

Notes: NSAIDs can cause increased risk of serious blood clotting events, like heart attack and stroke, which can be fatal. NSAIDs can also cause increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines which can be fatal. These events can occur at any time during use and without warning. Elder patients or people with history of these events are at greater risk.

Common Side Effects: Serious side effects include: heart attack, chest pain, coronary artery disease, exacerbation or new onset of hypertension, new onset heart failure, gastritis, gastric ulcer, gastrointestinal perforation, gastric bleeding, prolonged bleeding, changes in red and white blood cells, liver injury, facial swelling, skin rash, kidney damage, and pulmonary hypertension. Other side effects include: decreased hemoglobin, abdominal distress, swelling, dizziness, tinnitus, blurred vision, and headache.

Contraindications: Allergy or hypersensitivity to ibuprofen, other NSAIDs, and aspirin. History of aspirin sensitive asthma. History of bariatric surgery or history of gastric ulcer. History of coronary artery bypass graft (CABG) surgery. Avoid in people over 65 years of age if possible. Ibuprofen is identified as potentially inappropriate medication due to potential for gastric bleeding. Co-administration with other NSAIDs or aspirin.

Caution: Use in caution with existing cardiovascular disease, gastrointestinal disease, kidney and liver disease, or bleeding disorders.

Nature's Bounty Immune 24 HR + Vitamin C

(dietary supplement with Ester-C®)

Supplement Category: Dietary Supplement, Immune Support

FDA-Approved Uses:Not applicable. Dietary supplements are not approved by the FDA to diagnose, treat, cure, or prevent any disease.

Common Structure/Function Uses:

• Supports immune system function
• Supports upper respiratory health
• Provides antioxidant support
• Helps maintain vitamin C levels in the body
• Supports normal white blood cell function

Typical Adult Dosing:

Immune support:Take Nature's Bounty Immune 24 HR + Vitamin C as directed on the product label. Common product directions are 2 softgels daily, preferably with a meal.

Pregnancy: Consult with a medical provider before use during pregnancy.

Breastfeeding: Consult with a medical provider before use while breastfeeding.

Notes: This product is a dietary supplement, not a medication. Nature's Bounty describes this product as containing 1,000 mg Ester-C® per serving, plus Vitamin D, Zinc, Vitamin A, Elderberry, and Echinacea for immune and antioxidant support. Do not use this product as a substitute for a varied diet, appropriate medical care, or treatment recommended by a healthcare professional. Do not exceed the recommended serving size unless directed by a medical provider. This product has not been evaluated by the FDA to diagnose, treat, cure, or prevent any disease.

Common Side Effects: Gastrointestinal upset, nausea, diarrhea, stomach cramps, headache, unpleasant taste.

Contraindications: DO NOT TAKE if known allergy or hypersensitivity to any ingredient in the formulation, including Vitamin C, Elderberry, Echinacea, Zinc, Vitamin D, Vitamin A, gelatin, or other inactive ingredients.

Caution: Caution if taking other supplements or multivitamins containing Vitamin C, Vitamin D, Vitamin A, Zinc, Elderberry, or Echinacea to avoid excessive total daily intake. Caution with history of kidney stones, kidney disease, iron overload disorders, autoimmune conditions, liver disease, or chronic medical conditions. Caution with blood thinners, immunosuppressants, or other prescription medications due to potential ingredient interactions. Stop use and consult a medical provider if adverse reactions occur.

Appendix A: Pregnancy, Lactation, and Reproductive Potential Labeling

Purpose of This Appendix

This appendix summarizes how pregnancy, breastfeeding, and reproductive potential information should be interpreted in medication education materials. This appendix is based on the FDA Pregnancy and Lactation Labeling Rule (PLLR) framework for prescription drug labeling.

The FDA no longer uses the pregnancy letter categories A, B, C, D, and X in current prescription drug labeling. These categories were removed because they were considered confusing and overly simplistic and did not adequately communicate medication risk during pregnancy, lactation, or reproductive decision-making.

Current FDA labeling uses narrative risk information to help healthcare providers assess benefit and risk and counsel pregnant patients, breastfeeding patients, and patients of reproductive potential.

8.1 Pregnancy

Under current FDA labeling, the Pregnancy subsection may include the following elements when applicable:

Pregnancy Exposure RegistryIf a pregnancy exposure registry exists for a medication, labeling may include information about the registry and how pregnant patients may enroll or obtain additional information.

Risk SummaryThe pregnancy risk summary provides a concise summary of what is known about medication use during pregnancy. It may include available human data, animal data, and pharmacologic information when relevant. The risk summary may address whether available data identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Clinical ConsiderationsThis section may include clinically relevant information such as:

• Disease-associated maternal and/or embryo/fetal risk
• Dose adjustments during pregnancy and postpartum period
• Maternal adverse reactions
• Fetal/neonatal adverse reactions
• Labor or delivery considerations when applicable

DataThis section may summarize the human and/or animal data supporting the risk summary.

8.2 Lactation

Under current FDA labeling, the Lactation subsection may include the following elements when applicable:

Risk SummaryThe lactation risk summary may describe:

• Whether the medication is present in human milk
• Whether the medication affects the breastfed child
• Whether the medication affects milk production
• Relevant human or animal lactation data, if available

When human lactation data are available, FDA labeling gives priority to human data over animal data. If breastfeeding is contraindicated, that information should be stated first in the risk summary.

Clinical ConsiderationsThis section may include recommendations for minimizing exposure, monitoring the breastfed child, or managing potential adverse reactions when applicable.

DataThis section may summarize available human or animal lactation data, including measured drug levels in milk or infant exposure estimates when available.

8.3 Females and Males of Reproductive Potential

Under current FDA labeling, this subsection may include information about:

• Pregnancy testing
• Contraception
• Infertility

This section is included when a medication may affect pregnancy status, fertility, embryo-fetal development, or reproductive decision-making.

Legacy Pregnancy Letter Categories

(Historical reference only — no longer current FDA standard)

CategoryDefinitionAAdequate and well-controlled studies in pregnant women failed to demonstrate a risk to the fetus in the first trimester, and there is no evidence of risk in later trimesters.BAnimal reproduction studies failed to demonstrate fetal risk, but there are no adequate and well-controlled studies in pregnant women. Or: Animal studies showed an adverse effect, but adequate and well-controlled studies in pregnant women failed to demonstrate fetal risk.CAnimal reproduction studies showed an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans. Or: No animal reproduction studies and no adequate and well-controlled studies in humans are available. Potential benefits may warrant use in pregnant women despite potential risks.DThere is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. Potential benefits may warrant use in pregnant women despite potential risks.XStudies in animals or humans demonstrated fetal abnormalities. Or: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. The risks involved in use during pregnancy clearly outweigh potential benefits.

Standard Pregnancy Language for Medication Sheets

When current labeling provides a clear pregnancy risk statement:Pregnancy: Current labeling states [insert label-based risk summary]. Consult with a medical provider before use during pregnancy.

When human pregnancy data are limited:Pregnancy: Available human data are limited and are not sufficient to establish a drug-associated risk. Use during pregnancy only if the potential benefit justifies the potential risk. Consult with a medical provider.

When medication should be avoided at a specific pregnancy stage:Pregnancy: Avoid use during [insert trimester/week range] unless specifically advised by a medical provider due to [insert label-supported risk]. Consult with a medical provider.

When medication is contraindicated in pregnancy:Pregnancy: Use is contraindicated during pregnancy. Do not use if pregnant or planning to become pregnant unless labeling or a medical provider specifically indicates otherwise.

Standard Breastfeeding Language for Medication Sheets

When medication presence in human milk is unknown:Breastfeeding: It is not known whether this medication is present in human milk, whether it affects the breastfed infant, or whether it affects milk production. Consult with a medical provider before use while breastfeeding.

When medication is present in human milk:Breastfeeding: This medication is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed child. Consult with a medical provider.

When medication is expected to produce low infant exposure:Breastfeeding: Available data suggest infant exposure through breastmilk is expected to be low. Consult with a medical provider before use while breastfeeding, especially when nursing a newborn or preterm infant.

When breastfeeding is not recommended:Breastfeeding: Breastfeeding is not recommended during treatment with this medication and for [insert duration, if specified in labeling] after the last dose. Consult with a medical provider for individualized guidance.

When breastfeeding is contraindicated:Breastfeeding: Use is contraindicated during breastfeeding. Do not breastfeed during treatment unless current prescribing information or a medical provider specifically indicates otherwise.

This appendix is for medication education and labeling consistency only. It does not provide medical advice, diagnose any condition, recommend treatment, or replace the full prescribing information, product label, FDA-approved labeling, or guidance from a licensed medical provider. Current prescribing information should be reviewed because pregnancy, lactation, and reproductive-risk information may change as new data become available.