Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid

Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HCL. It is labelled by WALGREENS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0363-8757, application M013, label effective 20260609. It is one of 21 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL are most often described in connection with: temporary relief, minor aches, pains associated, sore throat, headache muscular. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for the temporary relief of minor aches and pains associated with: sore throat headache muscular aches backache

Directions take only as directed do not exceed 3 doses (30 mL each) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hours children under 12 yrs ask a doctor

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 21 drug label records with ACETAMINOPHEN, DIPHENHYDRAMINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid used for?
Uses for the temporary relief of minor aches and pains associated with: sore throat headache muscular aches backache

Who makes Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid?
WALGREENS is the labeler of record for Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid. 21 FDA label records share the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL?
Yes. 21 FDA drug label records list ACETAMINOPHEN, DIPHENHYDRAMINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.