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Sleep Aid Nighttime by Better Living Brands, LLC

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Better Living Brands, LLC
NDC Code: 21130-763

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.

Signature Care 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
  • 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
  • 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
  • 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

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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Simply Sleep®
active ingredient*

NDC 21130-763-12

Nighttime Sleep Aid

DIPHENHYDRAMINE HCl 25 mg
Nighttime Sleep-Aid

• For a restful night's sleep
• Safe, non-habit forming
• Contains no pain relievers

Actual Size

100 CAPLETS

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Simply Sleep®.                                   50844     REV0516E36712

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929

OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.

Signature Care 44-367


SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-763
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-763-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:21130-763-061 BOTTLE in 1 CARTON
2200 TABLET, FILM COATED in 1 BOTTLE
3NDC:21130-763-121 BOTTLE, PLASTIC in 1 CARTON
3100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(21130-763)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(21130-763)

Revised: 02/2017
 
Better Living Brands, LLC

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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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