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Sleep Aid by Kareway Product, Inc.

Medically reviewed on February 15, 2018

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0160

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 tablet)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

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
  • 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 beverages

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.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years and older

take 2 tablets at bedtime if needed or as directed by your doctor.

Other information
  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package label

Enter section text here

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0160
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 
MICROCRYSTALLINE WAX 
ANHYDROUS LACTOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
STEARIC ACID 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
ETHANETHIOL 
Product Characteristics
ColorblueScore2 pieces
ShapeROUNDSize9mm
FlavorImprint CodeRM
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0160-22 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET (TABLET) in 1 BLISTER PACK
2NDC:67510-0160-02 BLISTER PACK (BLISTER PACK) in 1 BOX
210 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/18/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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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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