SOMINEX MAX- diphenhydramine hcl tablet 
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 Max

Drug Facts

Active ingredient

(in each caplet)

Diphenhydramine HCl 50 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
  • drowsiness will occur

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

Directions

Other information

store at room temperature 20º- 25ºC (68º-77ºF)

Inactive ingredients

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

Questions?

1-866-255-5202 


PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH FORMULA
Sominex®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
16 TABLETS

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

SOMINEX MAX 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-505
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (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
ShapeCAPSULESize15mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-505-161 in 1 BOX06/01/2012
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-505-011 in 1 BOX06/01/201202/01/2019
2NDC:63029-505-0716 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: 1/2019
Document Id: 573b4f2e-a546-4e00-9b16-dc2439b5445b
Set id: e8f6991f-c47a-4d12-934b-04fdf092dac3
Version: 2
Effective Time: 20190130
 
Medtech Products Inc.