SLEEP TABS- diphenhydramine hcl tablet 
L&R Distributors, 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.

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Select Brand 44-189-Discontinued

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime Sleep-Aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

select brand®
the lower price name brand

NDC 15127-258-16

Sleep Tabs
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Wake Up Rested and Refreshed

Doctor preferred sleep ingredient

*Compare to the Active Ingredient of Original Formula Sominex®

16 TABLETS

Actual Size

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       REV0516C18921

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635

SATISFACTION GUARANTEED

Select Brand 44-189

Select Brand 44-189

SLEEP TABS 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-258
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 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;189
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-258-162 in 1 CARTON04/10/199008/03/2021
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 FINALpart33804/10/199008/03/2021
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-258)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-258)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(15127-258)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(15127-258)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(15127-258)

Revised: 5/2019
Document Id: 6f9739fa-4e82-47c3-a290-11699bf23677
Set id: 1bbdec11-72ca-417f-8a8c-175a8fe1003c
Version: 12
Effective Time: 20190529
 
L&R Distributors, Inc.