DIMETAPP COUGH AND ALLERGY- diphenhydramine hydrochloride tablet, chewable

Dimetapp by

Drug Labeling and Warnings

Dimetapp by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Diphenhydramine HCl 12.5 mg

• Active ingredients (in each chewable tablet): Purposes
• Diphenhydramine HCl 12.5 mg: Antihistamine/Cough suppresant

Uses

• temporarily relieves:
  • cough
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily alleviates the intensity of coughing

WARNINGS

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

• chew or crush tablets completely before swallowing, do not swallow tablets whole
• do not take more than 6 doses in 24 hours

• age: dose
• adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
• children 6 to under 12 years: take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
• children under 6 years: do not use

Other information

• store at 20-25°C (68-77°​F)
• avoid high humidity

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

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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:

• Cough
• Itchy throat
• Sneezing
• Runny nose

6+ years

24 CHEWABLE TABLETS

Grape-Flavored

INGREDIENTS AND APPEARANCE

DIMETAPP  COUGH AND ALLERGY
diphenhydramine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-370
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
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
Color	purple	Score	no score
Shape	ROUND	Size	12mm
Flavor	GRAPE	Imprint Code	DT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-370-24	4 in 1 CARTON	04/15/2024
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	04/15/2024

Labeler - Foundation Consumer Healthcare (079675882)