Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan), Ltd. for the product Daytime Severe Cold And Flu (NDC 53345-021). 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 capsule), 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 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
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.
Taking more than directed 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 & children 12 years of age and over | 2 softgels with water every 4 hours |
children 4 to under 12 years of age | ask a doctor |
children under 4 years of age | do not use |
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
DAYTIME SEVERE COLD AND FLU CAPSULES
Quantity : 3000 Capsules
NDC. No : 53345-021-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.