Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan), Ltd. for the product Nighttime Cold And Flu (NDC 53345-026). 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, otc - 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 15 mg
Doxylamine Succinate 6.25 mg
Pain reliever/ fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take:
Sore throat warningIf sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do not use
Keep out of reach of children.
Overdose warning
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 children even if you do not notice any signs or symptoms.
adults and children 12 years of age and over | take 2 softgels with water every 6 hours |
children 4 to 12 years of age | ask a doctor |
children under4 years o9f age | do not use |
When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
D&C Yellow # 10, FD&C Blue #1, 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
NIGHTTIME COLD AND FLU CAPSULES
Quantity : 4000 Capsules
NDC. No : 53345-026-01
IMPORTANT:
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"
* Please review the disclaimer below.