CHLORPHENIRAMINE MALEATE 4 MG- chlorpheniramine maleate tablet

Chlorpheniramine Maleate 4 mg by

Drug Labeling and Warnings

Chlorpheniramine Maleate 4 mg by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Warnings

Ask a doctor before use if you have

• glaucoma
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

GENERAL PRECAUTIONS

When using this product

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Drug Facts continued on back of label

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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: take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
• children 6 years to under 12 years: take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
• children under 6 years: do not use

Other information

• each tablet contains: calsium 40 mg
• store at 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes

HOW SUPPLIED

Product: 71335-0963

NDC: 71335-0963-1 30 TABLET in a BOTTLE

NDC: 71335-0963-2 60 TABLET in a BOTTLE

NDC: 71335-0963-3 100 TABLET in a BOTTLE

NDC: 71335-0963-4 120 TABLET in a BOTTLE

NDC: 71335-0963-5 40 TABLET in a BOTTLE

CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET

INGREDIENTS AND APPEARANCE

CHLORPHENIRAMINE MALEATE 4 MG 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0963(NDC:69618-022)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;016
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0963-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2018
2	NDC: 71335-0963-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2018
3	NDC: 71335-0963-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2018
4	NDC: 71335-0963-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2018
5	NDC: 71335-0963-5	40 in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2015

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0963) , RELABEL(71335-0963)