CHILDRENS BENADRYL CHEWABLES- diphenhydramine hydrochloride tablet, chewable 
Johnson & Johnson Consumer Inc.

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Children's Benadryl ® Chewables

Drug Facts

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

  • 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 alcohol 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 healthcare 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

Age (yr)Dose (chewable tablets)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)

Other information

Inactive ingredients

crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid

Questions or comments?

call 1-877-717-2824 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-232-01

Children's
Benadryl ®

ALLERGY

Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets

Chewables

4-6 Hours/Dose

RELIEF OF:

20
Chewable Tablets

Grape!
Flavored
Tablets

Actual Size

PRINCIPAL DISPLAY PANEL
CHILDRENS BENADRYL CHEWABLES 
diphenhydramine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ACACIA (UNII: 5C5403N26O)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TARTARIC ACID (UNII: W4888I119H)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-232-012 in 1 CARTON07/11/2016
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/11/2016
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0e315d98-a7d2-2980-e063-6294a90ae7d3
Set id: b08f71d8-a06c-41ba-8ed1-fbc41dbc1919
Version: 5
Effective Time: 20240105
 
Johnson & Johnson Consumer Inc.