CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable 
Wal-Mart Stores Inc

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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Equate 44-599

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 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

  • 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 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

Age (yr)
Dose (chewable tablets)
children under 2 years
 do not use
children 2 to 5 years
do not use unless directed by a doctor
children 6 to 11 years
1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)

Other information

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC 49035-599-09

equate™

Compare
to Children's
Benadryl®
Chewables Active
Ingredient*


Children's
ALLERGY RELIEF

Diphenhydramine HCl, 12.5 mg
Antihistamine

6 YEARS AND OLDER

Relief of:
• Sneezing         • Runny nose  
• Itchy throat or nose
• Itchy, watery eyes

Cherry Flavored

20 CHEWABLE TABLETS

Actual Size

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 Children’s Benadryl® Chewables.
50844                ORG031759909

Satisfaction guaranteed - Or we'll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.

Equate 44-599

Equate 44-599

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-599
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 12mm
Flavor CHERRY Imprint Code 44;599
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49035-599-44 3 in 1 CARTON 04/25/2011
1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:49035-599-09 4 in 1 CARTON 04/25/2011
2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 04/25/2011
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(49035-599)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(49035-599)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 PACK(49035-599)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 PACK(49035-599)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 PACK(49035-599)

Revised: 8/2017
Document Id: 0dd3ef9d-db90-45e7-8329-4168a1ccfbd8
Set id: 53a3e6a7-d625-4393-95eb-bb6f86e86cc1
Version: 7
Effective Time: 20170808
 
Wal-Mart Stores Inc