MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
KROGER COMPANY
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid for the relief of occasional sleeplessness
Authorization status:
OTC monograph final
Authorization number:
30142-228-32, 30142-228-40, 30142-228-64

MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated

KROGER COMPANY

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.

----------

Kroger® MAXIMUM STRENGTH Sleep Aid Softgels

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Us e

for the 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

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 avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of 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. 1-800-222-1222

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed

by a doctor

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide,

water

Questions or comments?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

GLUTEN FREE

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of

UNISOM® SLEEPGELS®**

NDC 30142-228-32

NDC 30142-228-40

NDC 30142-228-64

Kroger®

Sleep-Aid Softgels

MAXIMUM STRENGTH

Diphenhydramine HCI 50 mg

Nighttime Sleep Aid

Safe, Non-Habit Forming

32/40/64

LIQUID FILLED SOFTGELS one softgel per dose

actual size

**Unisom® SleepGels® is a registered trademark

of Chattem, Inc., Chattanooga, TN 37409.

Chattem, Inc., is not affiliated with The Kroger Co.

or this product.

MAXIMUM STRENGTH SLEEP AID

diphenhydramine hcl capsule, gelatin coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-228

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

DIPHENHYDRAMINE

50 mg

KROGER COMPANY

UNII:8 GTS8 2S8 3M)

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Product Characteristics

Color

blue

S core

no sco re

S hap e

OVAL

S iz e

13mm

Flavor

Imprint Code

20 6

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-228 -32

1 in 1 CARTON

0 4/17/20 19

1

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

2

NDC:30 142-228 -40

1 in 1 CARTON

0 4/17/20 19

2

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

3

NDC:30 142-228 -6 4

1 in 1 CARTON

0 4/17/20 19

3

6 4 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 rt338

0 4/17/20 19

Labeler -

KROGER COMPANY (006999528)

Registrant -

Spirit Pharmaceuticals LLC (179621011)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MEDGEL PRIVATE LIMITED

6 7738 549 8

ma nufa c ture (30 142-228 )

Revised: 9/2020

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