Otc - Active Ingredient
Active Ingredient: Each 20ml contains:
Acetaminophen 650 mg
Dextromethorphan 20 mg
Guaifenesin 400 mg
Phenylephrine 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Rapid Max Maximum Strength Cool And Clear - Cold, Flu And Sore Throat (NDC 71027-019). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient: Each 20ml contains:
Acetaminophen 650 mg
Dextromethorphan 20 mg
Guaifenesin 400 mg
Phenylephrine 10 mg
Purpose:
Pain reliever, Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes
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
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask doctor if
These could be signs of a serious condition
Keep this and all drugs out of the reach of children.
Overdose Warning: In case of accidental overdose, seek professional assistance 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.
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding,
ask a health professional before use.
Directions:
Other information
Inactive ingredients Anhydrous Citric Acid, Disodium EDTA-Copper, Sodium Benzoate, Sucralose, Sodium Citrate, Propyl Gallate, Xanthan gum, Glycerin, Propylene glycol, Sorbitol, FD&C Blue#1, FD&C Red# 40 and Purified Water.
(packs: 6oz) Kingston NDC# 71027-019-06
Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662
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