CHLORPHENIRAMINE MALEATE 4 MG- chlorpheniramine maleate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms of hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy nose or throat - itchy, watery eyes
Product summary:
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
Authorization status:
OTC monograph final
Authorization number:
71335-0963-1, 71335-0963-2, 71335-0963-3, 71335-0963-4, 71335-0963-5

CHLORPHENIRAMINE MALEATE 4 MG- 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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Chlorpheniramine Maleate 4 mg

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

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

If pregnant or breast-feeding, ask a health 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 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

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

BROKEN OR MISSING

* 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

CHLORPHENIRAMINE MALEATE 4 MG

chlorpheniramine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71335-0 9 6 3(NDC:6 9 6 18 -0 22)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

AP;0 16

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71335-0 9 6 3-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 9 /20 18

2

NDC:71335-0 9 6 3-2

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 9 /20 18

3

NDC:71335-0 9 6 3-3

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 9 /20 18

4

NDC:71335-0 9 6 3-4

120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 9 /20 18

5

NDC:71335-0 9 6 3-5

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 9 /20 18

Bryant Ranch Prepack

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

11/0 1/20 15

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(71335-0 9 6 3) , RELABEL(71335-0 9 6 3)

Revised: 2/2019

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