Active Ingredients (In Each Softgel)
Acetaminophen USP 325 mg
Dextromethorphan Hydrobromide USP 10 mg
Doxylamine succinate USP 6.25 mg
Phenylephrine Hydrochloride USP 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Private Limited for the product Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate And Phenylephrine Hydrochloride (NDC 35916-0167). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen USP 325 mg
Dextromethorphan Hydrobromide USP 10 mg
Doxylamine succinate USP 6.25 mg
Phenylephrine Hydrochloride USP 5 mg
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves common cold/flu symptoms:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
These could be signs of a serious condition.
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.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Adults & children 12 years & over | 2 softgels with water every 4 hours |
| Children 4 to under 12 years | Ask a doctor |
| Children under 4 years | Do not use |
Store at no greater than 25°C
FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution.
This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.
Softgel Healthcare Pvt. Ltd.,
Survey No. 20/1, Vandalur-Kelambakkam Road,
Pudupakkam Village, Kancheepuram District,
Tamilnadu - 603 103, India.
Mfg. Lic. No.: XXXXXXXXXXXX
* Please review the disclaimer below.