Allergy: Package Insert and Label Information

ALLERGY- chlorpheniramine maleate tablet
Preferred Pharmaceuticals 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.

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
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use

to make a child sleepy.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the 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

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over

1 tablet. Do not exceed 6 tablets in 24 hours.

children 6 to under 12 years

1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.

children under 6 years

do not use

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?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 68788-6951

4 Hour

Allergy Tablets
Chlorpheniramine Maleate
4 mg
Antihistamine

Relieves:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat

Actual Size

24 Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0419ML19412

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152Rev. 10/19 M-17 Re-order No. 700790

Repackaged By: Preferred Pharmaceuticals Inc.

Chlorpheniramine Maleate Tablets 4mg

Major 44-194

ALLERGY chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6951(NDC:0904-0012)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 44;194
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-6951-2 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68788-6951-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/24/2017
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-6951)

Revised: 04/2020 Preferred Pharmaceuticals Inc.

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