Allergy by CARDINAL HEALTH / LNK International, Inc. Leader 44-194

Allergy by

Drug Labeling and Warnings

Allergy by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY- chlorpheniramine maleate tablet 
CARDINAL HEALTH

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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Leader 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
  • 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 age

Other information

  • protect from excessive moisture 
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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?

1-800-426-9391 

Principal Display Panel

NDC: 37205-215-62

LEADER®

Compare to
Chlor-Trimeton® Allergy Tablets
active ingredient*

Allergy Tablets
Chlorpheniramine maleate

Antihistamine
4-hour relief

For Allergy Relief
 Sneezing Itchy, Watery Eyes Itchy Throat Runny Nose

SATISFACTION
GUARANTEED

24 TABLETS, 4 mg each

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 Tablets.           50844    REV0213H19408

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 1388099
www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed
or return to place of purchase for a full refund.

Leader 44-194

Leader 44-194

ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-215
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-215-622 in 1 CARTON12/19/199202/07/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 37205-215-781 in 1 CARTON12/19/199202/07/2020
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/199202/07/2020
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37205-215)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-215)

Revised: 4/2016
Document Id: be913622-4031-4129-bf19-335604b3e751
Set id: e9ebb570-ffe5-4811-b9a3-23f6de1a68d1
Version: 8
Effective Time: 20160411
 
CARDINAL HEALTH