FDA Label for Chlorpheniramine Maleate
View Indications, Usage & Precautions
Chlorpheniramine Maleate Product Label
The following document was submitted to the FDA by the labeler of this product Direct Rx. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient Section
Chlorpheniramine maleate 4 mg
Otc - Purpose Section
Antihistamine
Indications & Usage Section
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
Otc - Keep Out Of Reach Of Children Section
- Do not use
to make a child sleepy.
Ask a doctor before use if you have- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children If pregnant or breast-feeding,
taking sedatives or tranquilizers.
When using this productask a health professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration Section
adults and children
12 years of age
and over1 tablet every 4 to 6
hours. Do not take more than 6 tablets in 24 hours.children 6 to under 12 years of age 1/2 tablet (break tablet in half) every 4 to 6 hours.
Do not exceed 3 whole tablets in 24 hours.children under 6 years of age do not use this product in children under 6 years of age
Information For Patients Section
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive Ingredient Section
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Otc - Questions Section
(800) 616-2471
Warnings Section
Do not use
to make a child sleepy.
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding,
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 (1-800-222-1222) right away
Package Label.Principal Display Panel
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