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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-169(NDC:63029-555)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-169-011 in 1 CARTON09/22/2016
18 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/22/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-169) , repack(67751-169)

Revised: 11/2019
Document Id: 97de51a7-6389-796e-e053-2a95a90abad0
Set id: 9d2cbdff-2231-4d80-8481-22bcb8385506
Version: 2
Effective Time: 20191121
 
Navajo Manufacturing Company Inc.