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Drug Facts
Distributed By: J.P Business Enterprise
Lake Grove, NY 11755
The following Structured Product Label (SPL) was submitted to the FDA by J.p. Business Enterprise for the product Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate (NDC 59105-005). 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 other, otc - purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed By: J.P Business Enterprise
Lake Grove, NY 11755
| Active ingredients (in each softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan Hydrobromide 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take:
If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose can cause serious health problems. 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 and children 12 years of age and over | swallow 2 softgels with water every 6 hours |
| children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
1-888-333-9792
VALUMEDS
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
in
VICKS
® NyQUIL
®*
MULTI-SYMPTOM
NITE TIME
COLD & FLU NIGHTTIME RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
10 SOFTGELS
Liquid filled capsules
* Please review the disclaimer below.