SOMINEX- diphenhydramine hcl tablet 
GlaxoSmithKline Consumer Healthcare LP

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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Drug Facts

Active Ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Active Ingredient (in each caplet)

Diphenhydramine HCl 50 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 serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

 

(Original Formula)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Overdose warning: (Maximum Strength)

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (Original Formula)

•
adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by a doctor

Directions (Maximum Strength)

•
adults and children 12 years and older: take 1 caplet at bedtime if needed or as directed by your doctor

Other information (Original Formula)

•
each tablet contains: calcium 70 mg
•
store below 25°C (77°F)

Other information (Maximum Strength)

•
each caplet contains: calcium 50 mg
•
store below 25°C (77°F)

Inactive ingredients (Original Formula)

dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

Inactive ingredients (Maximum Strength)

carnauba wax, crospovidone, dibasic calcium phosphate, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, starch, titanium dioxide

Questions or comments?

1-800-245-1040 (English/Spanish) weekdays or visit essentialsforlivingwell.com

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Principal Display Panel

NDC 0135-0057-07

Sominex®

NIGHTTIME SLEEP-AID ·DIPHENHYDRAMINE HCl

ORIGINAL FORMULA

Safe, Effective & Non-Habit Forming

CONTAINS THE #1 DOCTOR-RECOMMENDED SLEEP-AID INGREDIENT

Helps You Fall Asleep Fast

16 TABLETS

©2011 GlaxoSmithKline

101383XA

Sominex Original 16 count tablet carton

Principal Display Panel

NDC 0135-0058-07

Sominex®

NIGHTTIME SLEEP-AID ·DIPHENHYDRAMINE HCl

MAXIMUM STRENGTH

 WAKE RESTED & REFRESHED

Safe, Effective & Non-Habit Forming

CONTAINS THE #1 DOCTOR-RECOMMENDED SLEEP-AID INGREDIENT

 One Caplet

Helps You Fall Asleep Fast

16 Caplets

©2011 GlaxoSmithKline

101389XA

Sominex Maximum Strength 16 count caplet carton
SOMINEX 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0057
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0057-0716 in 1 BLISTER PACK
2NDC:0135-0057-1132 in 1 BLISTER PACK
3NDC:0135-0057-1672 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/08/201009/30/2017
SOMINEX 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0058
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (UNII: 68401960MK)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0058-0716 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/08/201007/31/2015
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 2/2013
Document Id: 732fa64a-715f-4d21-a0e5-dfd0fb939c1d
Set id: 316ff3d0-b6f0-4565-ad88-de0b5be5a98b
Version: 3
Effective Time: 20130219
 
GlaxoSmithKline Consumer Healthcare LP