Equate Severe Cold Cough and Flu

Equate Severe Cold Cough and Flu is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by WALMART INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 79903-356, application M012, label effective 20260616. It is one of 7 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. 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 HYDROCHLORIDE are most often described in connection with: temporarily relieves, symptoms due, cold minor, sore throat, pain headache, runny nose, sneezing itchy, watery eyes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever

Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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 • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with rash or headache that lasts. 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 7 drug label records with ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 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.

What is Equate Severe Cold Cough and Flu used for?
Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever

Who makes Equate Severe Cold Cough and Flu?
WALMART INC. is the labeler of record for Equate Severe Cold Cough and Flu. 7 FDA label records share the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, 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 Equate Severe Cold Cough and Flu 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 Equate Severe Cold Cough and Flu 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 HYDROCHLORIDE?
Yes. 7 FDA drug label records list ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 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 Equate Severe Cold Cough and Flu been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.