Your browser does not support JavaScript! CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES INC]
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CHILDRENS ALLERGY RELIEF (diphenhydramine) tablet, orally disintegrating
[Wal-Mart Stores Inc]


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 12.5mg

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
  • with any other products 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 (1-800-222-1222) right away.

Directions

  • dissolve in mouth or chew before swallowing
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
children under 2 years of agedo not use 
children 2 to under 6 years of age

do not use unless directed by a doctor 

children under 6 to 12 years of age 1 to 2 tablets 
adults and children 12 years of age 2 to 4 tablets 

Other information

  •  store between 20º-25ºC (68º-86ºF).  Avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, magnesium stearate, mannitol, polytheylene and polypropylene polymers, stearic acid, sucralose

Questions?

 1-888-287-1915

Principal Display Panel

NDC 49035-599-44

equate®

Compare to Children's Benadryl® Allergy FastMelt® Active Ingredient*

Ages 6+
Children's
Allergy Relief
Diphenhydramine HCl 12.5 mg/Antihistamine

For the relief of:
• Sneezing            • Itchy throat
• Runny Nose       • Itchy, watery eyes

Cherry Flavor
18 Rapid Melts

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 ©Wal-Mart Stores, Inc.
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Benadryl® Allergy FastMelt® .
50844        ORG011159944

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

Equate 44-599

Equate 44-599

CHILDRENS ALLERGY RELIEF 
diphenhydramine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-599
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
CHERRY 
DEXTRATES 
MAGNESIUM STEARATE 
MANNITOL 
SUCRALOSE 
STEARIC ACID 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize10mm
FlavorCHERRYImprint Code 44;599
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-599-441 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2011
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-599)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-599)

Revised: 11/2012
 
Wal-Mart Stores Inc

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