Active Ingredients (In Each Softgel)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Guaifenesin USP 200 mg
Phenylephrine HCl USP 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Pvt Ltd for the product Acetaminophen, Guaifenesin, Phenylephrine Hcl And Dextromethorphan Hbr (NDC 35916-0166). 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 10 mg
Guaifenesin USP 200 mg
Phenylephrine HCl USP 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
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.
taking the blood thinning drug warfarin.
do not use more than directed.
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 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 |
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution
MAX STRENGTH
NDC 35916-0166-1
Compared to the active ingredient in Vicks® DayQuil ™ severe COLD & FLU LiquiCaps™
Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine HCl 5mg And Dextromethorphan HBr 10mg Softgelatin Capsules
Headache, Fever, Sore throat, Minor aches & Pains
Chest congestion, Thins & loosen mucus
Nasal congestion, Sinus Pressure
cough
24 Softgels
Day Time Severe Cold & Flu
(Non-Drowsy)
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