ALLERGY- chlorpheniramine maleate tablet 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Major 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
  • 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 over1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 yearsdo 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

DRUG: Allergy

GENERIC: Chlorpheniramine Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2961-0

COLOR: yellow

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 44;194

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CHLORPHENIRAMINE MALEATE 4mg in 1

INACTIVE INGREDIENT(S):

  • STARCH, CORN
  • D&C YELLOW NO. 10 ALUMINUM LAKE
  • ANHYDROUS LACTOSE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE

Remedy_Label

ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2961(NDC:0904-0012)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2961-030 in 1 BLISTER PACK; Type 0: Not a Combination Product12/07/202010/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/07/202010/12/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07886d0f-2df0-fa1f-e063-6394a90ad92f
Set id: 0074d2d3-c0c5-4183-98d1-00b0c2152410
Version: 4
Effective Time: 20231012
 
REMEDYREPACK INC.