SOMINEX- diphenhydramine hydrochloride tablet, film coated

Sominex by

Drug Labeling and Warnings

Sominex by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc., Navajo Manufacturing Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficultly 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 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 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 12 mg
  
• store at 20º- 25ºC (68º-77ºF)

Inactive ingredients

cellulose, microcrystalline, croscarmellose sodium, FD&C blue no. 1, hypromellose, lactose monohydrate, light mineral oil, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin

Questions?

1-866-255-5202 weekdays or visit www.sominex.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOMINEX 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-221(NDC:63029-554)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
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;S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-221-01	1 in 1 CARTON	06/01/2012
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	06/01/2012

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc		136941411	relabel(67751-221) , repack(67751-221)