Cold Medicine
FDA Label NDC 63654-600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Selder, S.a. De C.v. for the product Cold Medicine (NDC 63654-600). 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 - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each capsule)Acetaminophen 325 mg Chlorpheniramine Maleate 4 mgPhenylepherine Hydrochloride 10 mg

Otc - Purpose

PurposeAnalgesicAntihistamine Decongestant

Indications & Usage

Uses  temporarily relieves these symptoms due to common cold and allergies: • nasal congestion • runny nose • sneezing • watery eyes • fever • aches and pains

Warnings

Warnings Do exceedrecommended dosage

Otc - Ask Doctor

Ask a doctor before use you have• glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives

Otc - Stop Use

Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur• redness or swelling • these may be signs of a serious condition.

Otc - When Using

When using this product• you may get drowsy • avoid alcoholic drinks• alcohol, sedatives and tranquilizers may increase drowsiness• use caution when driving a motor vehicle or operating machinery•  excitability may occur, especially in childrenIf nervousness, dizziness or sleeplessness occur discontinue use and consult a doctorIf symptoms do not improve within 7 days, or are accompanied by fever, consult a doctorIf pregnant or breast feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Other

Drug Interaction Precautions• Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, orParkinson’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.

Dosage & Administration

Directions Adults and children 12 years of age and older; take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor.

Inactive Ingredient

Inactive Ingredients Lactose, stearic acid, povidone, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, FDC Yellow No. 5

Package Label.Principal Display Panel

Package Label

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