BENADRYL

Main information

  • Trade name:
  • BENADRYL diphenhydramine hydrochloride tablet film coated
  • Composition:
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENADRYL diphenhydramine hydrochloride tablet film coated
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

BENADRYL- diphenhydramine hydrochloride tablet, film coated

REMEDYREPACK INC.

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

Purpos e

Antihistamine

Us es

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 over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do 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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 178 6 -8 6 6 (NDC:50 58 0 -226 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

REMEDYREPACK INC.

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

pink

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

B;WL;25

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 178 6 -8 6 6 -

24 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

0 9 /0 2/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 9 /0 2/20 16

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 3/2017