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Allergy Relief by Cardinal Health

Medically reviewed on December 14, 2017

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 70000-0136

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.

Leader 44-329

Active ingredient (in each tablet)

Diphenhydramine HCl 25 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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 

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
  • marked 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
  • do not take more than 6 times in 24 hours

adults and children 12
years and over

1 to 2 tablets
children 6 to under 12
years
1 tablet
children under 6 yearsdo not use

Other information
  • each tablet contains: calcium 30 mg
  • 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 moisture
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel

LEADER

NDC 70000-0136-2

Allergy Relief

Diphenhydramine HCl, 25 mg
Antihistamine

For Allergy Relief

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

48 MINI TABLETS

ACTUAL SIZE

COMPARE TO BENADRYL® ALLERGY active ingredient*
100% Money Back Guarantee

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 Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy.

50844 REV1016A32922

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com      1-800-200-6313
Essential to Care™ since 1979

All LEADER™ Brand Products Have A
100% Money Back Guarantee

Return to place of purchase if not satisfied.

©2017 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

Leader 44-329

ALLERGY RELIEF 
diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
D&C RED NO. 27 ALUMINUM LAKE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;329
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0136-24 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
2NDC:70000-0136-12 BLISTER PACK in 1 CARTON
212 TABLET, COATED in 1 BLISTER PACK
3NDC:70000-0136-31 BOTTLE in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0136)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70000-0136)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(70000-0136), PACK(70000-0136)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(70000-0136)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0136)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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