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Sominex by GlaxoSmithKline Consumer Healthcare LP

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0057

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.

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

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 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0057
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0057-0716 TABLET in 1 BLISTER PACK
2NDC:0135-0057-1132 TABLET in 1 BLISTER PACK
3NDC:0135-0057-1672 TABLET 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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
SILICON DIOXIDE 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0058-0716 TABLET 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: 02/2013
 
GlaxoSmithKline Consumer Healthcare LP

See also...

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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