ANTIHISTAMINE ALLERGY - diphenhydramine hydrochloride tablet 
H E B

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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Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

  • 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

  • marked drowsiness may occur

  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

If pregnant of 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 right away. (1-800-222-1222)

Directions

 adults and children 12 years of age and over take 1 to 2 tablets
 children 6 to under 12 years of age take 1 tablet
 children under 6 years of age do not use this product in children under 6

Other information

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

* contains one or more of these ingredients

Questions or Comments?

Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Antihistamine Allergy

For Allergy Relief

Diphenhydramine Hydrochloride 25 mg

Compare to the Active Ingredient in Benadryl® Allergy Ultratab® **

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

HEB Antihistamine Allergy

Diphenhydramine HCl 25 mg

 


ANTIHISTAMINE ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-690
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
EGG PHOSPHOLIPIDS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
Product Characteristics
ColorPINKScore no score
ShapeCAPSULESize12mm
FlavorImprint Code T;61;V;25;S4
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:37808-690-484 BLISTER PACK (4 BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
112 TABLET (12 TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (37808-690-48)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/2011

Labeler - H E B (007924756)

Revised: 11/2012 H E B