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Allergy Relief by Harmon Store Inc.

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Harmon Store Inc.
NDC Code: 63940-329

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 44-329

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 drinks
  • 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 years1 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
  • protect from moisture
  • 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 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

CORE VALUES™

Compare to active ingredient in
Benadryl® Allergy ULTRATAB®

NDC 63940-329-03

Allergy Relief
Diphenhydramine HCl 25 mg

Antihistamine

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

Actual Size

24 coated mini-tabs

Easy to Swallow

*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Benadryl® Allergy ULTRATAB®.

50844       REV1016A32908

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

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

Core Values 44-329

ALLERGY RELIEF 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;329
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-329-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:63940-329-031 BOTTLE in 1 PACKAGE
210 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63940-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(63940-329), PACK(63940-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-329)

 
Harmon Store Inc.

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Medically reviewed on Sep 12, 2017

Further information

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

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