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Sleep Aid Nighttime by L&R Distributors, Inc.

Medically reviewed on December 12, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: L&R Distributors, Inc.
NDC Code: 15127-594

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.

Select Brand 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness 

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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. 

When using this product
  • use caution when driving a motor vehicle or operating machinery 
  • drowsiness will occur
  • avoid alcoholic beverages

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
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information
  • each caplet contains: calcium 30 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

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

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the lower price name brand

NDC 15127-594-24

NIGHTTIME

Sleep Aid
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Wake Up Rested and Refreshed

Does NOT Contain Pain Reliever
Safe, Non-habit Forming

*Compare to the Active Ingredient of Simply Sleep®

24 CAPLETS

Actual Size

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

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

Select Brand 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-594
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-594-242 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(15127-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(15127-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(15127-594), PACK(15127-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(15127-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(15127-594)

 
L&R Distributors, Inc.

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Further information

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

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