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Benadryl by REMEDYREPACK INC.

Medically reviewed on March 3, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: REMEDYREPACK INC.
NDC Code: 61786-866

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.

Benadryl ®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

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 alcoholic 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 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. (1-800-222-1222)

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information
  • each tablet contains: calcium 15 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

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

DRUG: Benadryl

GENERIC: Diphenhydramine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-866-36

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 11 mm

IMPRINT: B;WL;25

PACKAGING: 24 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Diphenhydramine Hydrochloride 25mg in 1

INACTIVE INGREDIENT(S):

  • Carnauba Wax
  • Microcrystalline Cellulose
  • Magnesium Stearate
  • Polyethylene Glycol, Unspecified
  • Polysorbate 80
  • Hypromellose, Unspecified
  • Croscarmellose Sodium
  • D&C Red no. 27
  • Dibasic Calcium Phosphate Dihydrate
  • Aluminum Oxide
  • Titanium Dioxide

BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-866(NDC:50580-226)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
ALUMINUM OXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint CodeB;WL;25
Contains    
Packaging
#Item CodePackage Description
1NDC:61786-866-3624 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/02/2016
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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