Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HBR
Labeler / manufacturerRARITAN PHARMACEUTICALS
RouteORAL
Drug classDrug class not supplied in source label
Product NDC68163-749
Label effective date2026-09-09
Official product label reference
DRx Choice maximum strength Severe Cough plus sore throat — RARITAN PHARMACEUTICALS
This page contains 16 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, oral route. Label set a096cb76-0d1c-4ca8-854a-5199da0bc8f7, version 4.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
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
Table text from source:
| Age | dose
| adults and children 12 years and over | 20 mL every 4 hours
| children under 12 years | do not use
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.
Active ingredient
Active ingredients (in each 20 mL) Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg
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
While using this medicine
When using this product do not use more than directed.
When to stop use and seek help
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.
Child safety
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.
Storage and handling
Other information ▪ each 20 mL contains: sodium 10 mg ▪ store at room temperature Do not refrigerate.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.