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Nightime Sleep Aid by Agile Pharmachem

Medically reviewed on September 27, 2016

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Agile Pharmachem
NDC Code: 58805-006

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.

DIPHENHYDRAMINE HCl 50mg, USP

Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Uses
  • For relief of occasional sleeplessness.

Directions
  • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
  • children under 12 years:do not use

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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

  • avoid alcoholic drinks

    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)

Other Information
  • save carton for full directions and warnings

Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-02 

NIGHTIME SLEEP AID 
diphenhydramine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 1000 
SORBITOL 
POLYVINYL ACETATE PHTHALATE 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code206
Contains    
Packaging
#Item CodePackage Description
1NDC:58805-006-02750 BOX in 1 BAG
148 CAPSULE, LIQUID FILLED in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2014
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

 
Agile Pharmachem

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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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