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Sominex

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Diphenhydramine HCl 25 mg

Diphenhydramine HCl 50 mg

Nighttime sleep-aid

helps reduce difficulty falling asleep

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.

  • •adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by a doctor
  • •adults and children 12 years and older: take 1 caplet at bedtime if needed or as directed by your doctor
  • each tablet contains: calcium 70 mg
  • •store below 25°C (77°F)
  • each caplet contains: calcium 50 mg
  • •store below 25°C (77°F)

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

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

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 Type Human otc drug label Item Code (Source) NDC:0135-0057
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
ALUMINUM OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
BLUE (light blue) 10 mm S ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0057-07 16 in 1 BLISTER PACK
2 NDC:0135-0057-11 32 in 1 BLISTER PACK
3 NDC:0135-0057-16 72 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-11-08


Sominex

diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0058
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
BLUE (light blue) 15 mm S CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0058-07 16 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-11-08


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Be sure to consult your doctor before taking any medication!
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