DIPHENHYDRAMINE HYDROCHLORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

DIPHENHYDRAMINE HYDROCHLORIDE

HIMPRIT PHARMACHEM PVT LTD

DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 over take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years do not use

DIPHENHYDRAMINE HYDROCHLORIDE 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

DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65437-037
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
BLUE 10 mm S5 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50000 in 1 BAG
2 75000 in 1 BAG
3 100000 in 1 BAG
4 NDC:65437-037-10 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-03-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.