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Sleep Tabs by Major Pharmaceuticals

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-4274

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.

Major 44-189

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to 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

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • do not drive a motor vehicle or operate machinery 
  • avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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
  • adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information
  • each tablet contains: calcium 60 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Principal Display Panel

MAJOR®

NDC 0904-4274-51

*Compare to the active ingredient
in Original Formula Sominex® 

Sleep Tabs

Diphenhydramine HCl
Night-Time Sleep Aid

50 TABLETS 25 mg each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®
50844    REV1014L18915

Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA        M-17
Rev. 01/15        Re-order No. 700607

Major 44-189

SLEEP TABS 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-4274
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;189
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-4274-511 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/25/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-4274)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-4274)

Revised: 03/2015
 
Major Pharmaceuticals

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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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