Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable
- NDC Code(s): 36800-585-44
- Packager: Topco Associates, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 20, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
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
-
Directions
- find right dose on chart below
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
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
- Questions or comments?
-
Principal Display Panel
+TopCare®
healthNDC 36800-585-44
COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT*
children's
Allergy ReliefDIPHENHYDRAMINE HCl 12.5 mg
CHEWABLE TABLETS - ANTIHISTAMINE4-6
HOURS/
DOSERELIEF OF:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat
18 CHEWABLE
TABLETSChew or crush tablets completely before swallowing.
For Ages 6 to 11 Years
GRAPE
FLAVORactual 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 REV1218B58544
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.comQUALITY
GUARANTEEDTopcare 44-585
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
diphenhydramine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-585 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 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color purple Score no score Shape ROUND Size 12mm Flavor GRAPE Imprint Code 44;585 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-585-44 3 in 1 CARTON 03/20/2009 1 6 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 Drug M012 03/20/2009 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(36800-585) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(36800-585) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(36800-585) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(36800-585) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(36800-585)