Otc - Active Ingredient
Chlorpheniramine Maleate 3mg
Phenylephrine Hydrochloride 10mg
Belladonna Total Alkaloid 0.133mg
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.
Chlorpheniramine Maleate 3mg
Phenylephrine Hydrochloride 10mg
Belladonna Total Alkaloid 0.133mg
■relieves these symptoms due to hay fever or other upper respiratory allergies:
Runny nose, Sneezing, Itchy, watery eyes, Itching of the nose or throat
Keep out of reach of children
■ 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
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).
cellulose, corn starch, magnesium stearate, sodium starch glycolate
For oral use only
* Please review the disclaimer below.