SOMNITABS- diphenhydramine hcl tablet
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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.

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Healthcare 44-189 Delisted

Active ingredient (in each tablet)

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

with any other product containing diphenhydramine, even one used on skin
for children under 12 years of age

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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 tablets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

each tablet contains: calcium 60 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

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE™

NDC 64092-010-16

*Compare to the active
ingredient in Original Formula Sominex®

Somnitabs
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid

An Aid to Sleep

ACTUAL SIZE

16 TABLETS

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 Medtech Products Inc., owner of the registered trademark Original Formula Sominex®.

50844 REV1019C18921

Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund

44-189

SOMNITABS
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64092-010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;189
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64092-010-16	2 in 1 CARTON	04/10/1990	11/11/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	04/10/1990	11/11/2022

Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(64092-010)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(64092-010)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(64092-010)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(64092-010)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(64092-010)

Revised: 12/2022

Document Id: 7da68f81-7e5e-4fa1-9989-351f9771be55

Set id: c050cb08-b6f4-4e7d-af94-f062d9c8e8c1

Version: 15

Effective Time: 20221206

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.