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 2022-06-24

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
USP Dissolution test is pending

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?

call 1-855-274-4122

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASONTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

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 (225 Tablets Bottle)

TO OPEN:

1. PUSH DOWN

2. TURN CAP

Signaturte

Care_®

Quality

Guaranteed

DO NOT USE

WITH OTHER

MEDICINES

CONTAINING

ACETAMINOPHEN

8 HOUR                                NDC 21130-108-35

ARTHRITIS

PAIN

RELIEVER

ACETAMINOPHEN

Extended-Release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For the temporary relief of                 225

minor arthritis pain                  Extended-Release

                                                     Tablets

Package Label Principal Display Panel 650 Mg (225 Tablets Container Carton)

Compare to Tylenol ^®8HR Arthritis Pain

active ingredient*

NDC 21130-108-35

Signature

Care_®

Quality Guaranteed

DO NOT USE WITH

OTHER MEDICINES

CONTAINING

ACETAMINOPHEN

8 HOUR

ARTHRITIS

PAIN RELIEVER

ACETAMINOPHEN                        Actual Size

Extended-Release                                06

Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For the temporary relief                225

of minor arthritis pain       Extended-release

                                               tablets

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
USP Dissolution test is pending

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?

call 1-855-274-4122

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASONTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

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 (225 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle))

TO OPEN:

1. PUSH DOWN

2. TURN CAP

Signaturte

Care_®

Quality

Guaranteed

DO NOT USE

WITH OTHER

MEDICINES

CONTAINING

ACETAMINOPHEN

8 HOUR                                NDC 21130-108-35

ARTHRITIS

PAIN

RELIEVER

ACETAMINOPHEN

Extended-Release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For the temporary relief of                 225

minor arthritis pain                  Extended-Release

                                                     Tablets

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

Compare to Tylenol ^®8HR Arthritis Pain

active ingredient*

NDC 21130-108-35

Signature

Care_®

Quality Guaranteed

DO NOT USE WITH

OTHER MEDICINES

CONTAINING

ACETAMINOPHEN

8 HOUR

ARTHRITIS

PAIN RELIEVER

ACETAMINOPHEN                        Actual Size

Extended-Release                                06

Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For the temporary relief                225

of minor arthritis pain       Extended-release

                                               tablets

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)", "unii": "8136Y38GY5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE B POTATO", "unii": "27NA468985", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 USP Dissolution test is pending ", "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? call 1-855-274-4122 DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASONTON, CA 94566-0009 1-888-723-3929 www.betterlivingbrandsLLC.com 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 (225 Tablets Bottle)": "TO OPEN: 1. PUSH DOWN 2. TURN CAP Signaturte Care ® Quality Guaranteed DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR NDC 21130-108-35 ARTHRITIS PAIN RELIEVER ACETAMINOPHEN Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of 225 minor arthritis pain Extended-Release Tablets ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton)": "Compare to Tylenol ® 8HR Arthritis Pain active ingredient* NDC 21130-108-35 Signature Care ® Quality Guaranteed DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR ARTHRITIS PAIN RELIEVER ACETAMINOPHEN Actual Size Extended-Release 06 Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief 225 of minor arthritis pain Extended-release tablets "}