BENADRYL

Main information

  • Trade name:
  • BENADRYL- diphenhydramine hydrochloride
  • Composition:
  • diphenhydramine hydrochloride 25 mg
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENADRYL- diphenhydramine hydrochloride
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Antihistamine - 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 - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat - temporarily relieves these symptoms due to the common cold: runny nose sneezing - runny nose - sneezing

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 50580-370-01
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

BENADRYL- diphenhydramine hydrochloride

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

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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

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 carton tape and foil inner seal imprinted with "SAFETY

SEAL®" are broken or missing

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)

PRINCIPAL DISPLAY PANEL

100+48 = 148

ULTRATABS *

TABLETS

Benadryl

WORKS WHEN YOU

NEED IT MOST™

*small tablet size

®

®

BENADRYL

diphenhydramine hydrochloride kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 58 0 -370

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 58 0 -370 -0 1

1 in 1 PACKAGE

0 6 /12/20 17

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

10 0

Pa rt 2

4 BLISTER PACK

Part 1 of 2

BENADRYL

diphenhydramine hydrochloride tablet, film coated

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

diphenhydra mine hydro chlo ride (UNII: TC2D6 JAD40 ) (diphenhydramine -

UNII:8 GTS8 2S8 3M)

diphe nhydra mine

hydro c hlo ride

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ca rna uba wa x (UNII: R12CBM0 EIZ)

cro sca rmello se so dium (UNII: M28 OL1HH48 )

D&C red no . 2 7 a luminum la ke (UNII: ZK6 4F7XSTX)

diba sic ca lcium pho spha te dihydra te (UNII: O7TSZ9 7GEP)

hypro mello se, unspecified (UNII: 3NXW29 V3WO)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

po lyethylene g lyco l, unspecified (UNII: 3WJQ0 SDW1A)

po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

tita nium 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

1 in 1 CARTON

1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 6 /0 4/20 12

Part 2 of 2

BENADRYL

diphenhydramine hydrochloride tablet, film coated

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

diphenhydra mine hydro chlo ride (UNII: TC2D6 JAD40 ) (diphenhydramine -

UNII:8 GTS8 2S8 3M)

diphe nhydra mine

hydro c hlo ride

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ca rna uba wa x (UNII: R12CBM0 EIZ)

cro sca rmello se so dium (UNII: M28 OL1HH48 )

D&C red no . 2 7 a luminum la ke (UNII: ZK6 4F7XSTX)

diba sic ca lcium pho spha te dihydra te (UNII: O7TSZ9 7GEP)

hypro mello se, unspecified (UNII: 3NXW29 V3WO)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

po lyethylene g lyco l, unspecified (UNII: 3WJQ0 SDW1A)

po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

tita nium 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

4 in 1 CARTON

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 6 /0 4/20 12

Marketing Information

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 6 /12/20 17

Labeler -

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2018