SLEEP-AID CHEWABLES NIGHTTIME- 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:
Nighttime sleep-aid - reduces time to fall asleep if you have difficulty falling asleep - for relief of occasional sleeplessness
Authorization status:
OTC monograph final
Authorization number:
69842-958-44

SLEEP-AID CHEWABLES NIGHTTIME- 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-Sleep Aid

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

reduces time to fall asleep if you have difficulty falling asleep

for relief of occasional sleeplessness

Warnings

Do not use

for children under 12 years of age

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

avoid alcoholic beverages.

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious

underlying medical illness.

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

do not take more than directed

chew or crush tablets completely before swallowing; do not swallow tablets whole

take only one dose per day (24 hours)

adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a

doctor

children under 12 years: do not use

Other information

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

TORN OR BROKEN

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

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

CVSHealth

Compare to the active ingredient in

VICKS ZzzQuil

Sleep-Aid

Chewables

DIPHENHYDRAMINE HCl, 25 mg

CHEWABLE TABLETS

Nighttime sleep-aid

Non-habit forming tablets

For a restful night's sleep

Not for treating pain, cold or flu

Grape Flavor

18 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

Actual Size

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

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered

trademark VICKS® ZzzQuil®.

SLEEP-AID.

50844 REV0119A68544

Nig httim e

50844 REV0119A68544

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-11112

CVS Quality

Money Back Guarantee

CVS 4 4 -685

SLEEP-AID CHEWABLES NIGHTTIME

diphenhydramine hcl tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-9 58

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)

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)

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

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 42-9 58 -44 3 in 1 CARTON

0 7/31/20 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 rt338

0 7/31/20 18

CVS Pharmacy

OTC MONOGRAPH FINAL

pa rt338

0 7/31/20 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

MANUFACTURE(6 9 8 42-9 58 ) , PACK(6 9 8 42-9 58 )

Revised: 12/2019

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