ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

ACETAMINOPHEN AND 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

Active ingredients (in each Caplet)	Purpose
Acetaminophen 500 mg	Pain reliever/ fever reducer
Diphenhydramine HCL 25 mg	Sleep Aid

Uses

Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness

Warnings

Alcohol Warnings

If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

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

Ask a doctor before use if you have

• * a breathing problem such as emphysema or chronic bronchitis
• * glaucoma
• * difficulty in urination due to enlargement of the prostate gland

ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers

When using this product

• * do not exceed recommended dosage
• * avoid alcoholic beverages
• * marked drowsiness may occur
• * do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• * sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness
• * new symptoms occur
• * redness or swelling is present
• * pain gets worse or lasts more than 10 days
• * fever gets worse or lasts more than 3 days

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

Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Direction

• * use as directed
• * adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor
• * Children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

• * Store at room temperature

Inactive ingredients

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1

PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label

ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
Each Film coated Tablet Contains:
ACETAMEINOPHEN 500 mg
DIPHENHYDRAMINE HCL 25 mg

Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-041-31

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

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65437-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL (Capsule Shaped)	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65437-041-31	1 in 1 DRUM
1		31000 in 1 BAG
2	NDC: 65437-041-50	1 in 1 DRUM
2		50000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/01/2010

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)