Acetainophen Tablets Usp 500 Mg

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Sodium Metabisulfite Silicon Dioxide Cellulose, Microcrystalline Croscarmellose Sodium Polyethylene Glycol Stearic Acid Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance

Imprint: S;500 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-07-01

Medication Information

Purpose

Pain reliever/ fever reducer

Description

Drug Facts

Uses

Temporarily relieves minor aches and pains due to :

*
headache
*
backache
*
the common cold
*
menstrual cramps

*
muscular aches
*
arthritis
*
toothache
*
reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and Ask a doctor if

*
fever gets worse or lasts for more than 3 days
*
redness or swelling is present
*
pain gets worse or lasts for more than 10 days
*
new symptoms occur

Section 50570-1

Do not use

*
with any other product containing acetaminophen

Section 53414-9

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

Direction

*
do not use more that directed (see overdose warning)
*
adults and children 12 years and over : take 2 caplets every 6 hours as needed
*
do not take more than 8 caplets in 24 hours
*
Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

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.

Overdose Warning

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.

Other Information

*
Store at room temperature

Inactive Ingredients

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Principal Display Panel 500 Mg Tablet Shipper Label

ACETAMINOPHEN TABLETS USP 500 mg

Each Film coated Tablet Contains:

ACETAMINOPHEN 500 MG

Lot No :

MFG. DATE :

Exp. Date :

Jar No. :

Quantity : 31000 Tablets

NDC. No : 65437-040-31

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"

Structured Label Content

Uses

Temporarily relieves minor aches and pains due to :

*
headache
*
backache
*
the common cold
*
menstrual cramps

*
muscular aches
*
arthritis
*
toothache
*
reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and Ask a doctor if

*
fever gets worse or lasts for more than 3 days
*
redness or swelling is present
*
pain gets worse or lasts for more than 10 days
*
new symptoms occur

Section 50570-1 (50570-1)

Do not use

*
with any other product containing acetaminophen

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/ fever reducer

Direction

*
do not use more that directed (see overdose warning)
*
adults and children 12 years and over : take 2 caplets every 6 hours as needed
*
do not take more than 8 caplets in 24 hours
*
Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

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.

Overdose Warning

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.

Other Information (Other information)

*
Store at room temperature

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate

Active Ingredients (in Each Caplet) (Active ingredients (in each Caplet))

Acetaminophen 500 mg

Principal Display Panel 500 Mg Tablet Shipper Label (PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label)

ACETAMINOPHEN TABLETS USP 500 mg

Each Film coated Tablet Contains:

ACETAMINOPHEN 500 MG

Lot No :

MFG. DATE :

Exp. Date :

Jar No. :

Quantity : 31000 Tablets

NDC. No : 65437-040-31

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"

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves minor aches and pains due to : * headache * backache * the common cold * menstrual cramps * muscular aches * arthritis * toothache * reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and Ask a doctor if * fever gets worse or lasts for more than 3 days * redness or swelling is present * pain gets worse or lasts for more than 10 days * new symptoms occur", "50570-1": "Do not use * with any other product containing acetaminophen", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "Purpose": "Pain reliever/ fever reducer", "Direction": "* do not use more that directed (see overdose warning) * adults and children 12 years and over : take 2 caplets every 6 hours as needed * do not take more than 8 caplets in 24 hours * Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.", "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.", "Overdose Warning": "Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.", "Other information": "* Store at room temperature", "Inactive ingredients": "croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate", "Active ingredients (in each Caplet)": "Acetaminophen 500 mg", "PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label": "ACETAMINOPHEN TABLETS USP 500 mg Each Film coated Tablet Contains: ACETAMINOPHEN 500 MG Lot No : MFG. DATE : Exp. Date : Jar No. : Quantity : 31000 Tablets NDC. No : 65437-040-31 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""}

Acetainophen Tablets Usp 500 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information