Otc - Active Ingredient
Active Ingredients
Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mgThe following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Cold Relief Severe Pain Cough (NDC 52904-456). 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, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mgPain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant
Directions: adults and children 12 years of age and over • take 2 tablets with water every 6-8 hours, as needed • do not take more than 8 tablets in 24 hours children under 12 years of age • do not give to children under 12 years of age
Uses: or the temporary relief of the following cold symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loose phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever
If pregnant or breast-feeding baby, ask a health professional
before use.
KEEP OUT OF REACH OF CHILDREN.
Inactive ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid
MM1
* Please review the disclaimer below.