DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by HIMPRIT PHARMACHEM PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

DOSAGE & ADMINISTRATION

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"

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65437-037
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL (CAPSULE-SHAPED)	Size	10mm
Flavor		Imprint Code	S5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65437-037-05	1 in 1 DRUM
1		50000 in 1 BAG
2	NDC: 65437-037-07	1 in 1 DRUM
2		75000 in 1 BAG
3	NDC: 65437-037-10	1 in 1 DRUM
3		100000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	03/01/2010

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)