Active Ingredients(In Each Softgel)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Private Limited for the product Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate (NDC 35916-0154). 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 HBr USP 15 mg
Doxylamine succinate USP 6.25 mg
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
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.
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 yrs & over | 2 softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan solution, water
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 – 603103, India
Mfg. Lic. No: xxxxxxxxxxxxxx
NDC Code: 35916-0154-1
*Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM
Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules
Fever, Sore Throat, Headache, Minor Aches & Pains
Runny Nose & Sneezing
Cough
Night time
(Cold & Flu - 12 Softgels)
* Please review the disclaimer below.