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Sleep Aid Nighttime by PLD Acquisitions LLC DBA Avéma Pharma Solutions

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: PLD Acquisitions LLC DBA Avéma Pharma Solutions
NDC Code: 63548-0400

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.

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

For relief of occasional sleeplessness

Warnings

Do not use
  • in children under 12 years of age
  • with any other products 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 sedative or tranquilizers.

When using this product,

avoid alcoholic drinks.

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 right away. (1-800-222-1222)

Directions
  • take only one dose (2 caplets) per day (24 hours)
  • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information
  • each caplet contains: calcium 25 mg
  • store between 20-25°C (68-77°F); excursions permitted between 15-30ºC (59-86ºF) 

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Tylenol® Simply Sleep®†

Nighttime Sleep-Aid

Diphenhydramine HCl, 25 mg

Does NOT contain pain reliever

Fall asleep fast

Wake up rested

Non habit-forming

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor Tylenol® Simply Sleep®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Nighttime Sleep-Aid

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeS25
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-0400-11000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33801/02/2010
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 03/2017
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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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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