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NDC 71335-0963-04 Chlorpheniramine Maleate 4 mg 4 mg/1 Details

Chlorpheniramine Maleate 4 mg 4 mg/1

Chlorpheniramine Maleate 4 mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CHLORPHENIRAMINE MALEATE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 71335-0963-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Product Information

NDC	71335-0963
Product ID	71335-0963_54681242-c861-4415-b5c0-d3ab55b62be1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Chlorpheniramine Maleate 4 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine Maleate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4
Active Ingredient Units	mg/1
Substance Name	CHLORPHENIRAMINE MALEATE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-0963-04 (71335096304)

Pricing Information	N/A
NDC Package Code	71335-0963-4
Billing NDC	71335096304
Package	120 TABLET in 1 BOTTLE (71335-0963-4)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54681242-c861-4415-b5c0-d3ab55b62be1 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

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

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

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

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

PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4mg 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

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)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0963-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2018
2	NDC:71335-0963-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
3	NDC:71335-0963-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
4	NDC:71335-0963-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
5	NDC:71335-0963-5	40 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

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

Revised: 2/2022

Document Id: 54681242-c861-4415-b5c0-d3ab55b62be1

Set id: 54681242-c861-4415-b5c0-d3ab55b62be1

Version: 7

Effective Time: 20220214

Search by Drug Name or NDC

NDC 71335-0963-04 Chlorpheniramine Maleate 4 mg 4 mg/1 Details

Chlorpheniramine Maleate 4 mg 4 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-0963-04 (71335096304)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 54681242-c861-4415-b5c0-d3ab55b62be1 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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