ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

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
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat - temporarily relieves these symptoms due to the common cold: sneezing runny nose - sneezing - runny nose
Authorization status:
OTC monograph final
Authorization number:
69842-685-44

ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

CVS Pharmacy

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.

----------

CVS 44-685-Allergy

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

sneezing

runny nose

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

difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

marked drowsiness may occur

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic beverages

use caution 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 doses in 24 hours

adults and children 12 years

and over

1 to 2 chewable

tablets

children 6 to under 12 years 1 chewable tablet

children under 6 years

do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

avoid high humidity

see end flap for expiration date and lot number

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C

blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid,

sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS Health™

Compare to the active ingredient in Benadryl

Chewable Tablets

Allergy Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 25 mg

Antihistamine

Relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat

For Ages 6 Years & Over

18 CHEWABLE TABLETS

Actual Size

Grape Flavored

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DO NOT USE IF INDIVIDUAL BLISTER UNITS ARE BROKEN OR OPEN.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2018 CVS/pharmacy

CVS.com 1-800-SHOP CVS

V-18615

CVS Quality

Money Back Guarantee

50844 ORG041868544

CVS Health 4 4 -685

ALLERGY RELIEF

diphenhydramine hcl tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-6 8 5

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

D&C RED NO . 2 7 ALUMINUM LAKE (UNII: ZK6 4F7XSTX)

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

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

MANNITO L (UNII: 3OWL53L36 A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

PURPLE

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

GRAPE

Imprint Code

44;6 8 5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-6 8 5-44 3 in 1 CARTON

0 5/31/20 18

1

6 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 5/31/20 18

CVS Pharmacy

OTC MONOGRAPH FINAL

pa rt341

0 5/31/20 18

Labeler -

CVS Pharmacy (062312574)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(6 9 8 42-6 8 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(6 9 8 42-6 8 5)

Revised: 4/2020

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