SOMNITABS- diphenhydramine hcl tablet 
FRED'S, INC.

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.

----------

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

Freds 44-189

SOMNITABS 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-189
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorBLUE (light) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;189
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-189-212 in 1 CARTON04/10/199004/08/2022
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
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/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55315-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(55315-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55315-189)

Revised: 6/2020
 
FRED'S, INC.