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Sleep Aid by Chain Drug Consortium, LLC

Medically reviewed on October 26, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-189

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

Use

to help reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • emphysema

  • chronic bronchitis

  • glaucoma

  • difficulty in urination due to an enlargement of the 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 for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant of breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

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

Directions
  • adults and children 12 years of age and over: take 2 caplets (50 mg) at bedtime if needed or as directed by a doctor

Other information
  • each caplet contains: calcium 85 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Nytol®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and silicon dioxide.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

*Compare to the active ingredient in Nytol®

SLEEP AID

Diphenhydramine Hydrochloride 25 mg

Nighttime Sleep Aid

Distributed by:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 25 mg

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-189
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, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code93XF;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-189-601 BOTTLE in 1 BOX
160 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33607/12/2010
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, 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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