SOMINEX- diphenhydramine hydrochloride tablet, film coated 
Medtech Products 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-Original

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

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

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)

PRINCIPAL DISPLAY PANEL

ORIGINAL FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

16 TABLETS

PRINCIPAL DISPLAY PANEL ORIGINAL FORMULA Sominex® NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 16 TABLETS

PRINCIPAL DISPLAY PANEL

ORIGINAL FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 

32 TABLETS

PRINCIPAL DISPLAY PANEL ORIGINAL FORMULA Sominex® NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 32 TABLETS

PRINCIPAL DISPLAY PANEL

ORIGINAL FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 

72 TABLETS

PRINCIPAL DISPLAY PANEL ORIGINAL FORMULA Sominex® NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 72 TABLETS

SOMINEX 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-554
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
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
ColorBLUE (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code S;S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-554-324 in 1 BOX06/01/2012
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-554-162 in 1 BOX06/01/2012
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63029-554-019 in 1 BOX06/01/2012
38 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 5/2020
Document Id: 8e28a028-79cd-4f6f-93bb-220c993ed35f
Set id: f7858ecf-8498-4465-85d8-3e7814737573
Version: 1
Effective Time: 20200518
 
Medtech Products Inc.