Otc - Active Ingredient
Active ingredient (in each tablet)
Chlorpheniramine maleate 4 mg
Medique Chlorphen Tablet
FDA Label NDC 47682-169
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique Chlorphen (NDC 47682-169). 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 - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
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
Warnings
Warnings
Do not use to make a child sleepy.
Otc - Ask Doctor
Ask a doctor before use if you have
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before us if you are taking sedatives or tranquilizers.
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-1222) right away.
Dosage & Administration
Directions
Adults and children (12 years and older): 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age
Other Safety Information
Other information
■ tamper evident sealed packets
■ do not use any opened or torn packets
■ store at 77°F (25°C); excursions permitted between 59°-86°F (15°-30°C)
■ protect from excessive moisture
■ use by expiration date on packet
Inactive Ingredient
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Otc - Questions
Questions or comments? Call 1-800-634-7680
Medique Chlorpen Label
Medique ®
Chlorphen
Allergy and Hay Fever Relief
Alivio a las algergias y la fiebre del heno
Antihistamine • Chlorpheniramine Maleate 4mg
Antihistminico • Maleato de Clorfeniramina 4mg
Pull To Open
Tire Para Abrir
250 Tablets
(250 x 1)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
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