Day-Time Cold/Flu Relief

Day-Time Cold/Flu Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL. It is labelled by AptaPharma Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 76281-506, application M012, label effective 20260510. It is one of 25 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE 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, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, fever nasal, congestion cough. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ fever ■ nasal congestion ■ cough due to minor throat and bronchial irritation

Directions ■ take only as recommended (see overdose warning) ■ use dosage cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours age dose adults & children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 to under 12 years 15 mL (1 TBSP) every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday while usina 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

FDA lists 25 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE 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.

1 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 Day-Time Cold/Flu Relief used for?
Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ fever ■ nasal congestion ■ cough due to minor throat and bronchial irritation

Who makes Day-Time Cold/Flu Relief?
AptaPharma Inc. is the labeler of record for Day-Time Cold/Flu Relief. 25 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE 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 Day-Time Cold/Flu Relief 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 Day-Time Cold/Flu Relief 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, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?
Yes. 25 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE 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 Day-Time Cold/Flu Relief been recalled?
1 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.