Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl · Capsule, Liquid Filled · Oral
Active ingredient
Active ingredients (in each softgelatin capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant
Uses
Uses
• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains
• headache
• cough
• sore throat
• nasal and sinus congestion
• temporarily reduces fever
Warnings
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 or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock If a skin or general allergic 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 ● 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● cough with excessive phlegm (mucus) ● difficulty in urination due to enlargement of the prostate gland ● persistent or chronic cough such 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
When using this product
When using this product do not exceed recommended dosage
Stop use and ask a doctor
Stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs
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 In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. children under 12 years: do not use
Inactive ingredients
Inactive ingredients FD&C yellow no.5, FD&C yellow no.6, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide
Label text from the FDA structured product label by Softgel Healthcare Private Limited (revised Apr 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenylephrine Hydrochloride in 1 product
- Dextromethorphan Hydrobromide in 1 product
- Acetaminophen in 1 product
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 35916-0188 | Phenylephrine Hydrochloride 5 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Acetaminophen 325 mg/1 Capsule, Liquid Filled | Softgel Healthcare Private Limited | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg used for?
Uses • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever
Who makes Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg?
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg is listed by 1 labeler in the FDA NDC directory, including Softgel Healthcare Private Limited.