SLEEP AID- diphenhydramine hcl 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:
Rite Aid Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid - for relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep
Authorization status:
OTC monograph final
Authorization number:
11822-3670-2, 11822-3670-4, 11822-3670-8

SLEEP AID- diphenhydramine hcl tablet, film coated

Rite Aid Corporation

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.

----------

Rite Aid 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

reduces time to fall asleep if you have difficulty falling asleep

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 right away.

Directions

do not take more than directed

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years: do not use

Other information

each caplet contains: calcium 30 mg

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

TORN OR BROKEN

protect from moisture

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

see end flap for expiration date and lot number

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc,

titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

RITE

AID®

PHARMACY

Compare to the active ingredient of

Simply Sleep®*

NIGHTTIME

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

nighttime sleep-aid

safe, effective, and non-habit forming

not for treating pain, cold or flu

ACTUAL SIZE

24

CAPLETS

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 Johnson &

Johnson Corporation, owner of the registered trademark Simply

Sleep®. 50844 REV1019D36708

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money

Rite Aid 4 4 -367

SLEEP AID

diphenhydramine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:118 22-36 70

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C BLUE NO . 1 ALUMINUM LAKE (UNII: J9 EQA3S2JM)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

44;36 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:118 22-36 70 -8

2 in 1 CARTON

0 6 /10 /20 0 0

1

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

2

NDC:118 22-36 70 -4

1 in 1 CARTON

0 6 /10 /20 0 0

2

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

Rite Aid Corporation

3

NDC:118 22-36 70 -2

1 in 1 CARTON

0 6 /10 /20 0 0

3

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 rt338

0 6 /10 /20 0 0

Labeler -

Rite Aid Corporation (014578892)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(118 22-36 70 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(118 22-36 70 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

MANUFACTURE(118 22-36 70 ) , PACK(118 22-36 70 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(118 22-36 70 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(118 22-36 70 )

Revised: 4/2020

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