ALLERGY TIME- chlorpheniramine maleate tablet
Bryant Ranch Prepack

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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242R CHLOR MAL

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

Purpose: Antihistamine

Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:

runny nose, sneezing, itching of the nose or throat, itch, watery eyes

Warnings

Ask a doctor before use if you have:

glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty 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; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery

If pregnant or breast-feeding ask a health professional before use.

Directions

Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 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, not to exceed 3 whole tablets in 24 hours

Children under 6 years of age - do not use

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.

HOW SUPPLIED

Product: 71335-0061

Chlorpheniramine Maleate 4mg Tablet

ALLERGY TIME
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0061(NDC:49483-242)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL242
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71335-0061-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2017	10/31/2018
2	NDC:71335-0061-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2017	10/31/2018
3	NDC:71335-0061-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2017	10/31/2018
4	NDC:71335-0061-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2017	10/31/2018
5	NDC:71335-0061-5	40 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2017	10/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/08/2011	10/31/2018

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0061) , RELABEL(71335-0061)

Revised: 3/2019

Document Id: 10300414-eee0-474f-96a4-852ee8e220cd

Set id: bf7de3c1-48d0-4261-b671-e34408128385

Version: 3

Effective Time: 20190321

Bryant Ranch Prepack