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DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form
TABLET, FILM COATED
Labeler
HIMPRIT PHARMACHEM PVT LTD
Label updated
2010-02-03
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

relief of occasional sleeplessness

Warnings

Label information

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Label information

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

Label information

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

Label information

When using this product

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

Label information

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.

Label information

If pregnant or breast-feeding, ask a health professional before use.

Label information

Keep out of reach of children.

복용법·사용법

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
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"

[Image in the official label — see DailyMed source]

DailyMed Set ID: d46fff27-1a0f-42b8-b247-d2d9d4d17ac7 · Version 1
NDC: 65437-037