ALLERGY RELIEF- 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:
Harmon Store Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat
Authorization status:
OTC monograph final
Authorization number:
63940-194-08

ALLERGY RELIEF- chlorpheniramine maleate tablet

Harmon Store Inc.

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.

----------

Core Values 44-194

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:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

Warnings

Do not use

to make a child sleepy.

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble 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

drowsiness may occur

avoid alcoholic beverages

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 professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 12

years of age and over

1 tablet every 4 to 6

hours. Do not take more

than 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.

Do not exceed 3 whole

tablets in 24 hours.

children under 6 years

of age

do not use this product in

children under 6 years of

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

protect from excessive moisture

see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline

cellulose

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

CORE ALUES™

Compare to active ingredient in Chlor-Trimeton Allergy

NDC 63940-194-08

Allergy Relief

Chlorpheniramine maleate 4 mg

Antihis tamine

Relieves:

Sneezing Itchy, Watery Eyes

Runny Nose Itchy Throat

Actual Size

24 tablets 4 Hour

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered

trademark Chlor-Trimeton Allergy.

50844 ORG021319408

Distributed by: Liberty Procurement, Inc.,

650 Liberty Ave., Union, NJ 07083 U.S.A.

Satisfaction Guaranteed Or Your Money Back

Visit us at www.facevalues.com

Core Values 4 4 -194

ALLERGY RELIEF

chlorpheniramine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 40 -19 4

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

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 ALUMINUM LAKE (UNII: CQ3XH3DET6 )

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

Product Characteristics

Color

YELLOW

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

44;19 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 39 40 -19 4-0 8

2 in 1 CARTON

12/19 /19 9 2

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

12/19 /19 9 2

Labeler -

Harmon Store Inc. (804085293)

Harmon Store Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(6 39 40 -19 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(6 39 40 -19 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(6 39 40 -19 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(6 39 40 -19 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(6 39 40 -19 4)

Revised: 5/2020

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