Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd for the product Cough And Cold Plus (NDC 53345-045). 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 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
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.
Do not use to sedate children.
These could be signs of a serious condition.
Butylated Hydroxyanisole (BHA), D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink
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Cough and Cold plus Capsules
Each softgel contains: Acetaminophen 325 mg Phenylephrine HCl 5 mg
Chlorpheniramine Maleate 2 mg Dextromethorphan HBr 10 mg
Quantity: 4000 Capsules
NDC No.:53345-045-01
MADE IN CHINA
IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86)°F
* Please review the disclaimer below.