Chlorpheniramine Maleate 12 Mg
Antihistamine
Allergy Relief Tablet, Film Coated, Extended Release
FDA Label NDC 69842-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Allergy Relief (NDC 69842-017). 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 chlorpheniramine maleate 12 mg, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat
Warnings
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
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alchohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088
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 right away.
Directions
adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: ask a doctor
Other Information
each tablet contains: calcium 28 mg
store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)
protect from excessive moisture
Inactive Ingredients
calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate
Purpose
Chlorpheniramine maleate 12 mg is used as an antihistamine.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Principal Display Panel
Allergy Relief
CHLORPHENIRAMINE MALEATE, 12 mg
Antihistamine
12 Hour Relief of:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat
24 EXTENDED RELEASE TABLETS
Carton Front Panel (E6e972a9 Figure 1)
Carton Back Panel (E6e972a9 Figure 2)
* Please review the disclaimer below.
