DRx Choice maximum strength Severe

Acetaminophen, Dextromethorphan HBr · Solution · Oral

Over the counter Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Active ingredients (in each 20 mL) Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg

Purpose

Purposes Pain reliever/fever reducer Cough suppressant

Uses

Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 doses in any 24 hours period, which is the maximum daily amount ▪ 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

Do not use ▪ 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. ▪ 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

Ask a doctor before use if you have ▪ liver disease ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking any other pain reliever/fever reducer

When using this product

When using this product do not use more than directed.

Stop use and ask a doctor

Stop use and ask a doctor if ▪ pain or cough gets worse or lasts more than 7 days ▪ 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.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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.

Directions

Directions ▪ do not take more than 6 doses in any 24-hour period ▪ do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ this adult product is not intended for use in children under 12 years of age Age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use

Other information

Other information ▪ each 20 mL contains: sodium 10 mg ▪ store at room temperature Do not refrigerate.

Inactive ingredients

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red No 40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions?

Questions or comments? 1-866-467-2748

Label text from the FDA structured product label by RARITAN PHARMACEUTICALS (revised Sep 9, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

DRx Choice maximum strength Severe NDC products (1)

NDCStrength & formLabelerType
68163-749Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL
Solution
RARITAN PHARMACEUTICALSOTC MONOGRAPH DRUG

Frequently asked questions

What is DRx Choice maximum strength Severe used for?

Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever

Who makes DRx Choice maximum strength Severe?

DRx Choice maximum strength Severe is listed by 1 labeler in the FDA NDC directory, including RARITAN PHARMACEUTICALS.