DIMETAPP COUGH AND ALLERGY- diphenhydramine hydrochloride tablet, chewable 
Foundation Consumer Healthcare

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Dimetapp Cough and Allergy Chewable

Drug Facts

Diphenhydramine HCl 12.5 mg

Active ingredients (in each chewable tablet)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine/Cough suppresant

Uses

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a vehicle or operating machinery
  • excitability may occur, expecially in children

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

agedose
adults and children 12 years and overtake 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
children 6 to under 12 yearstake 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose

Questions or comments?

Call 1-888-594-0828weekdays 9 AM to 5PM EST

Distributed by:

Foundation Consumer Healthcare, LLC

Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 24 ct Carton

CHILDREN'S

Dimetapp

DIPHENHYDRAMINE HCl, 12.5 mg

(Antihistamine/Cough Suppressant)

GREAT CHEWABLE TASTE

Cough & Allergy

Relieves + comforts:

6+ years

24 CHEWABLE TABLETS

Grape-Flavored

Dimetapp - 24ct Carton

DIMETAPP  COUGH AND ALLERGY
diphenhydramine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-370
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
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
DEXTRATES (UNII: G263MI44RU)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code DT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-370-244 in 1 CARTON04/15/2024
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/15/2024
Labeler - Foundation Consumer Healthcare (079675882)

Revised: 4/2024
Document Id: 15d9c0b3-b510-242a-e063-6294a90a3946
Set id: 15b0f5ff-202a-d19f-e063-6394a90af2b8
Version: 2
Effective Time: 20240415
 
Foundation Consumer Healthcare