Diphenhydramine Hydrochloride
FDA Label NDC 65437-037

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Himprit Pharmachem Pvt Ltd for the product Diphenhydramine Hydrochloride (NDC 65437-037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, use, directions, other information, inactive ingredients, principal display panel - 25 mg label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

relief of occasional sleeplessness

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"

Principal Display Panel (Diphenhydramine 01)

Principal Display Panel (Diphenhydramine 01)

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