DRX CHOICE Daytime and Nighttime Cold and Flu Relief

DRX CHOICE Daytime and Nighttime Cold and Flu Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE. It is labelled by Raritan Pharmaceuticals Inc and marketed as a human otc drug product. Identifiers on file: NDC 68163-064, application M012, label effective 20260806. 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, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, common cold, flu symptoms, nasal congestion, daytime only, headache minor, pains cough, bronchial irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves common cold or flu symptoms: ▪ Nasal congestion (Daytime only) ▪ headache ▪ minor aches and pains ▪ cough due to minor throat and bronchial irritation ▪ sore throat ▪ fever ▪ runny nose & sneezing (Nighttime only)

Directions ▪ take only as directed ▪ Do not exceed 8 softgels per 24 hrs Age Daytime Nighttime adults and children 12 years of age and over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs children under 12 years of age Ask doctor Ask doctor children under 4 years Do not use Do not use If taking Daytime and Nighttime Softgels carefully read each label to ensure dosing

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 8 softgels 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. ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ▪ liver disease ▪ Heart disease (Daytime only) ▪ High blood pressure (Daytime only) ▪ Thyroid disease (Daytime only) ▪ Diabetes (Daytime only) ▪ Trouble urinating due to enlarged prostate gland ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only) ▪ cough that occurs with too much phlegm (mucus) ▪ glaucoma (Nighttime only) ▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only) Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers (Nighttime Only) ▪ taking the blood thinning drug warfarin When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children (Nighttime only) ▪ marked drowsiness may occur (Nighttime only) ▪ avoid alcoholic drinks (Nighttime only) ▪ alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) ▪ be careful when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if ▪ you get nervous, dizzy or sleepless (Daytime Only) ▪ pain or cough gets worse or lasts more than 7 days (Nighttime Only) ▪ pain, nasal congestion or cough gets worse or lasts more than 7 days (Daytime only) ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ 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. In case of overdose, get medical help or contact a Poison Control Center right away at 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.

What is DRX CHOICE Daytime and Nighttime Cold and Flu Relief used for?
Uses ▪ temporarily relieves common cold or flu symptoms: ▪ Nasal congestion (Daytime only) ▪ headache ▪ minor aches and pains ▪ cough due to minor throat and bronchial irritation ▪ sore throat ▪ fever ▪ runny nose & sneezing (Nighttime only)

Who makes DRX CHOICE Daytime and Nighttime Cold and Flu Relief?
Raritan Pharmaceuticals Inc is the labeler of record for DRX CHOICE Daytime and Nighttime Cold and Flu Relief.

Is DRX CHOICE Daytime and Nighttime Cold and 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.

Has DRX CHOICE Daytime and Nighttime Cold and Flu Relief 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.