DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
CVS Pharmacy, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose 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 ■ Temporarily relieves these symptoms due to the common cold: ■ Runny nose ■ Sneezing
Authorization status:
OTC monograph final
Authorization number:
69842-981-08

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DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, film

coated

CVS Pharmacy, 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.

----------

2834A-CVS

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

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 (1-800-222-1222) right away.

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 37 mg

■ Store between 20-25° C (68-77° F). Protect from light.

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline

Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin

Questions or comments?

1-800-231-4670

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the

registered trademark Benadryl® Allergy LIQUIGELS®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR

MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2020 CVS/pharmacy CVS.com®

1-800-SHOP CVS

Product of China

V-34601

CVS Health

Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*

Allergy Relief

Diphehydramine HCl, 25 mg

Antihistamine

Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat

200 Tablets

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-9 8 1

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

CVS Pharmacy, Inc

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

TRIACETIN (UNII: XHX3C3X6 73)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

CPC;28 24

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-9 8 1-0 8

1 in 1 CARTON

0 9 /23/20 20

1

20 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 mo no graph final

pa rt341

0 9 /23/20 20

Labeler -

CVS Pharmacy, Inc (062312574)

Revised: 11/2020

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