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Sominex by Navajo Manufacturing Company Inc.

Medically reviewed on September 22, 2016

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-169

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.

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 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-169(NDC:63029-555)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
MINERAL OIL 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-169-011 PACKET in 1 CARTON
18 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/22/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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