SOMINEX- diphenhydramine hydrochloride tablet
Navajo Manufacturing Company 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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Sominex

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCI 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

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

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 beverages • be careful when driving a motor vehicle or operating machinery

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 accidental overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor.

Other information

• each tablet contains: calcium 10mg
• store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue no.1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin.

Questions?

1-866-255-5202 weekdays

Package Labeling:

Sominex

SOMINEX
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67751-169(NDC:63029-555)
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)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67751-169-01	1 in 1 CARTON	09/22/2016
1		8 in 1 PACKET; 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	09/22/2016	09/01/2019

Labeler - Navajo Manufacturing Company Inc. (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc.		136941411	relabel(67751-169) , repack(67751-169)

Revised: 3/2023

Document Id: f70bb1d0-7562-027d-e053-6294a90af08d

Set id: 9d2cbdff-2231-4d80-8481-22bcb8385506

Version: 3

Effective Time: 20230316

Navajo Manufacturing Company Inc.