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DIPHENHYDRAMINE HYDROCHLORIDE by HIMPRIT PHARMACHEM PVT LTD

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: HIMPRIT PHARMACHEM PVT LTD
NDC Code: 65437-037

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 TABLETS 25 mg BLUE

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

relief of occasional sleeplessness

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

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

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

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

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.

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

Directions
adults and children 12 years and overtake 2 caplets at bedtime if needed or as directed by a doctor
children under 12 yearsdo not use

Other information
  • each caplet contains: calcium 20 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, cellulose, croscarmellose sodium dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide

PRINCIPAL DISPLAY PANEL - 25 mg Label

DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE
Each Film coated Tablet Contains:

DIPHENHYDRAMINE HCL 25 MG

Lot No:Jar No.:
MFG. DATE:Quantity: 100,000 Tablets
Exp. Date:NDC. No: 65437-037-10

WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-037
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
TITANIUM DIOXIDE 
WATER 
D&C RED NO. 27 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (CAPSULE-SHAPED) Size10mm
FlavorImprint CodeS5
Contains    
Packaging
#Item CodePackage Description
1NDC:65437-037-051 BAG (BAG) in 1 DRUM
150000 TABLET, FILM COATED (TABLET) in 1 BAG
2NDC:65437-037-071 BAG (BAG) in 1 DRUM
275000 TABLET, FILM COATED (TABLET) in 1 BAG
3NDC:65437-037-101 BAG (BAG) in 1 DRUM
3100000 TABLET, FILM COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33803/01/2010
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

 
HIMPRIT PHARMACHEM PVT LTD

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Medically reviewed on Feb 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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