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Chlorpheniramine Tablets: Package Insert / Prescribing Info

Package insert / product label
Generic name: chlorpheniramine maleate
Dosage form: tablet
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

ACTIVE INGREDIENT (IN EACH TABLET)

Chlorpheniramine Maleate 4 mg

PURPOSE

Antihistamine

Indications and Usage for Chlorpheniramine Tablets

temporarily relieves these 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 or ■ 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

■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful 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 accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ adults and children 12 years and over: 1 tablet ■ children 6 to under 12 years: 1/2 tablet ■ children under 6 years: consult a doctor

Other information

■ save carton for full directions and warnings ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

D.&C. Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

DISPLAY PANEL

picture of carton

CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeAZ246
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62211-246-9324 in 1 PACKAGE
2NDC:62211-246-9975000 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/12/2010
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)

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