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Somnitabs

Medically reviewed by Drugs.com. Last updated on Jun 12, 2020.

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: FRED'S, INC.
NDC Code: 55315-189

Freds Pharmacy 44-189-Delisted

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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
  • avoid alcoholic beverages
  • use caution 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 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments? 1-800-426-9391

Principal Display Panel

fred's
Pharmacy

NDC 55315-189-21

ACTUAL
SIZE

Somnitabs
Diphenhydramine HCl 25 mg - Nighttime Sleep-Aid

WAKE UP RESTED AND REFRESHED

16 TABLETS

Compare to the active ingredient in:
Original Formula
Sominex®*

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Prestige Brands, Inc., owner of the registered
trademark Original Formula Sominex®.
50844        REV0516E18921

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100%
satisfaction
guaranteed
Questions or comments: 1-855-331-FRED (3733)

Freds 44-189

SOMNITABS 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-189
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 ALUMINUM LAKE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
STEARIC ACID 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorBLUE (light) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;189
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-189-212 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/10/199004/08/2022
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-189)

 
FRED'S, INC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.