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Diphenhydramine HCl by Softech Pharma Pvt. Ltd

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Softech Pharma Pvt. Ltd
NDC Code: 48769-060

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 25 mg

Drug Facts

Active Ingredient in each Softgel

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Keep out of reach of Children

Uses
  • for relief of occassional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other Information
  • store at 20-25˚C (68-77˚F)
  • avoid excessive heat above 40˚C (104˚F) and high humidity
  • protect from light

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-060
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 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOL 400 
PROPYLPARABEN 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorpurpleScoreno score
ShapecapsuleSize7mm
FlavorImprint CodeR60
Contains    
Packaging
#Item CodePackage Description
1NDC:48769-060-995000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/01/2013
Labeler - Softech Pharma Pvt. Ltd (677111277)
Establishment
NameAddressID/FEIOperations
Softech Pharma Pvt. Ltd677111277manufacture(48769-060)

Revised: 12/2012
 
Softech Pharma Pvt. Ltd

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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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