CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet
Contract Pharmacal Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0997

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active ingredient

(in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

sneezing
runny nose
itchy, watery eyes
itchy throat

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an enlarged prostate gland

When using this product

drowsiness may occur
avoid alcoholic drinks
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 care 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 of age and over	take one tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
children 6 to under 12 years of age	take ½ tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours
children under 6 years of age	see a physician

Other information

store at 2˚-30˚C (36˚ – 86˚F)
side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Inactive ingredient

D&C Yellow #10 Lake, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch and Stearic Acid

*This product is not manufactured or by Schering-Plough, owner of the registered trademark Chlor-Trimeton®

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

R11/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-0997
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow (Pale yellow)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC;997
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-0997-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2001	06/30/2014
2	NDC:10267-0997-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2001	06/30/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/24/2001	06/30/2014

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-0997)

Revised: 10/2017

Document Id: 5be8768a-f47a-36bc-e053-2991aa0a3ddc

Set id: 92548c25-29b1-46b3-a408-9ee5ffa319b9

Version: 2

Effective Time: 20171019

Contract Pharmacal Corp.