Contac Gold
FDA Label NDC 72689-0035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Contac Gold (NDC 72689-0035). 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, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Chlorpheniramine Maleate 3mg
Phenylephrine Hydrochloride 10mg
Belladonna Total Alkaloid 0.133mg

Otc - Purpose

■relieves these symptoms due to hay fever or other upper respiratory allergies:
Runny nose, Sneezing, Itchy, watery eyes, Itching of the nose or throat

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ adult and children 15 years of age and older: 1 capsules three times a day
■ children 11 to under 15 years of age: 1/2-2/3 capsules three times a day
■ children 8 to under 11 years of age: 1/2 capsules three times a day
■ children under 8 years of age: ask a doctor

Warnings

WARNING: Do not use if you have ever had an allergic reaction to this product or any of its ingredients, or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

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

When using this product:

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: Not recommended
if pregnant: Ask a health professional before use


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Store at room temperature, 15–30°C (59–86°F).

Inactive Ingredient

cellulose, corn starch, magnesium stearate, sodium starch glycolate

Dosage & Administration

For oral use only

Package Label.Principal Display Panel

1 (Contac)

1 (Contac)

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