Cold Relief Severe Pain Cough
FDA Label NDC 52904-456

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The 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.

Otc - Active Ingredient

Active Ingredients

Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mg


Otc - Purpose

Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

Dosage & Administration

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

Indications & Usage

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

Warnings

Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing any of the above active ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional  conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure •thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are •taking the blood thinning drug warfarin • taking sedatives or tranquilizers Whenusing this product • do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase the drowsiness effect • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness,or sleeplessness occur • pain or nasal congestion or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional
before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredient

Inactive ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

Package Label.Principal Display Panel

MM1

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