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SLEEP-AID by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: International Laboratories, LLC
NDC Code: 54458-857

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.

International Laboratories, Inc. Sleep-Aid Drug Facts

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

 taking sedatives or tranquilizers

When using this product
  • avoid alcoholic drinks
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if
  • sleeplessness persists continuously for more than 2 weeks.  Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children. 

Overdose warning: 

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions
adults and children 12 years and overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 yearsdo not use

Other information
  • each caplet contains: calcium 15 mg
  • store at 20-25ºC (68-77ºF).  Avoid high humidity.  Protect from light.

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide.

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

Drug Facts

 

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Simply Sleep®

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl 25 MG

  • For a restful night’s sleep
  • Safe, non-habit forming

Does not contain pain reliever

Actual size

LIFT HERE TO OPEN

14 MINI-CAPLETS

Sleep Aid

 

SLEEP-AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-857(NDC:59779-431)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
STARCH, PREGELATINIZED CORN 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeL431
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-857-1414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33805/27/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
International Laboratories, LLC023569924RELABEL(54458-857), REPACK(54458-857)

 
International Laboratories, LLC

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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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