Your browser does not support JavaScript! ANTIHISTAMINE ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE, COATED [H E B]
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ANTIHISTAMINE ALLERGY (diphenhydramine hcl) capsule, coated
[H E B]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • 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 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 right away.

Directions

  • take every 4 to 6 hours

  • do not take more than 6 doses in 24 hours

adults and children 12 years of age and over

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

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • 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

Principal Display Panel

Compare to Benadryl® Allergy Ultratab® active ingredient*

NDC 37808-329-08

H-E-B®

ANTIHISTAMINE ALLERGY
For Allergy Relief
Diphenhydramine Hydrochloride, 25 mg

• Sneezing            • Itchy, watery eyes
• Runny Nose       • Itchy throat

Does Not Contain Gluten

24 Tablets

*This product is not manfucatured or distributed by McNeil Consumer Healthcare, owner of the registered Benadryl® Allergy Ultratab®.
50844        ORG051232908        1212

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

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

HEB 44-329

HEB 44-329

ANTIHISTAMINE ALLERGY 
diphenhydramine hcl capsule, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-329-082 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37808-329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37808-329)

Revised: 2/2013
 
H E B

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