Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 325 mg/1
Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl · CAPSULE, LIQUID FILLED · Softgel Healthcare Private Limited
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg is a capsule, liquid filled containing acetaminophen, dextromethorphan hbr and phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Softgel Healthcare Private Limited.
Key Facts
- Brand Name
- Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
- Generic Name
- Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl
- NDC Code (Product)
35916-0188- Manufacturer
- Softgel Healthcare Private Limited
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 03/21/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
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
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.
Frequently Asked Questions
What is Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg used for?
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg contains Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.
Is Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg a controlled substance?
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg is not classified as a controlled substance by the DEA.
What is the generic name for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg?
The generic name for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg is Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl. There are no other listed brand versions of Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl.
What is the NDC code for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 325 mg/1?
The NDC (National Drug Code) for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 325 mg/1 is 35916-0188, listed by Softgel Healthcare Private Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)