DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Silicon Dioxide Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type B Potato Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: I;06 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2021-05-25

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

Uses

temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed (see overdose warning).

Adults:

take 2 tablets every 8 hours with water
swallow whole; do not crush, chew, split or dissolve
do not take more than 6 tablets in 24 hours
do not use for more than 10 days unless directed by a doctor.

Under 18 years of age:

ask a doctor

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Other Information

store at 20^o to 25^oC (68^o to 77^oF). Avoid excessive heat 40^oC (104^oF).
do not use if carton is opened or foil inner seal is broken
Meets USP dissolution test 3

Inactive Ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/22/2009

Stop Use and Ask A Doctor If

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

These could be signs of a serious condition.

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

Keep Out of Reach of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel 650 Mg (24 Tablet Container Label)

NDC 30142-157-07

Kroger_®

             health

TO OPEN: PUSH DOWN, TURN CAP

8 HOUR

Arthritis Pain

Acetaminophen Extended-Release

Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

PAIN RELIEVER/                24 EXTENDED-

FEVER REDUCER             RELEASE TABLETS

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Package Label Principal Display Panel 650 Mg (225 Tablet Container Label)

NDC 30142-157-35

Kroger_®

health

COMPARE TO THE ACTIVE INGREDIENT

OF TYLENOL^® 8HR ARTHRITIS PAIN *

EASY

OPEN

CAP

8 HOUR

Arthritis Pain

Acetaminophen

Extended-Release Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

THIS PACKAGE FOR HOUSEHOLDS

WITHOUT YOUNG CHILDERN

DO NOT USE WITH OTHER MEDICINES                ACTUAL SIZE

CONTAINING ACETAMINOPHEN

PAIN RELIEVER/                    225 EXTENDED-

FEVER REDUCER                 RELEASE TABLETS

Package Label Principal Display Panel 650 Mg (24 Tablets Container Carton)

NDC 30142-157-07

COMPARE TO THE ACTIVE INGREDIENT

OF TYLENOL^® 8HR ARTHRITIS PAIN ^*

Kroger_®

            health

TO OPEN:

PUSH DOWN, TURN CAP

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

8 HOUR

Arthritis Pain

Acetaminophen Extended-Release Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

PAIN RELIEVER/            24 EXTENDED-

FEVER REDUCER          RELEASE TABLETS

ACTUAL SIZE

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed (see overdose warning).

Adults:

take 2 tablets every 8 hours with water
swallow whole; do not crush, chew, split or dissolve
do not take more than 6 tablets in 24 hours
do not use for more than 10 days unless directed by a doctor.

Under 18 years of age:

ask a doctor

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Other Information (Other information)

store at 20^o to 25^oC (68^o to 77^oF). Avoid excessive heat 40^oC (104^oF).
do not use if carton is opened or foil inner seal is broken
Meets USP dissolution test 3

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/22/2009

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

These could be signs of a serious condition.

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

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel 650 Mg (24 Tablet Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Container Label))

NDC 30142-157-07

Kroger_®

             health

TO OPEN: PUSH DOWN, TURN CAP

8 HOUR

Arthritis Pain

Acetaminophen Extended-Release

Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

PAIN RELIEVER/                24 EXTENDED-

FEVER REDUCER             RELEASE TABLETS

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Package Label Principal Display Panel 650 Mg (225 Tablet Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Container Label))

NDC 30142-157-35

Kroger_®

health

COMPARE TO THE ACTIVE INGREDIENT

OF TYLENOL^® 8HR ARTHRITIS PAIN *

EASY

OPEN

CAP

8 HOUR

Arthritis Pain

Acetaminophen

Extended-Release Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

THIS PACKAGE FOR HOUSEHOLDS

WITHOUT YOUNG CHILDERN

DO NOT USE WITH OTHER MEDICINES                ACTUAL SIZE

CONTAINING ACETAMINOPHEN

PAIN RELIEVER/                    225 EXTENDED-

FEVER REDUCER                 RELEASE TABLETS

Package Label Principal Display Panel 650 Mg (24 Tablets Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton))

NDC 30142-157-07

COMPARE TO THE ACTIVE INGREDIENT

OF TYLENOL^® 8HR ARTHRITIS PAIN ^*

Kroger_®

            health

TO OPEN:

PUSH DOWN, TURN CAP

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

8 HOUR

Arthritis Pain

Acetaminophen Extended-Release Tablets USP, 650 mg

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

PAIN RELIEVER/            24 EXTENDED-

FEVER REDUCER          RELEASE TABLETS

ACTUAL SIZE

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Directions": "do not take more than directed (see overdose warning). Adults: take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor. Under 18 years of age: ask a doctor", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "Drug Facts": "Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg", "Other information": "store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3 ", "Inactive ingredients": "colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments? 1-800-632-6900 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA Code: TS/DRUGS/22/2009", "Stop use and ask a doctor if": "pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.", "Keep out of reach of children.": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Container Label)": "NDC 30142-157-07 Kroger ® health TO OPEN: PUSH DOWN, TURN CAP 8 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN PAIN RELIEVER/ 24 EXTENDED- FEVER REDUCER RELEASE TABLETS DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Container Label)": "NDC 30142-157-35 Kroger ® health COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL ® 8HR ARTHRITIS PAIN * EASY OPEN CAP 8 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDERN DO NOT USE WITH OTHER MEDICINES ACTUAL SIZE CONTAINING ACETAMINOPHEN PAIN RELIEVER/ 225 EXTENDED- FEVER REDUCER RELEASE TABLETS ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton)": "NDC 30142-157-07 COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL ® 8HR ARTHRITIS PAIN * Kroger ® health TO OPEN: PUSH DOWN, TURN CAP DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN PAIN RELIEVER/ 24 EXTENDED- FEVER REDUCER RELEASE TABLETS ACTUAL SIZE"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information