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 2022-10-13

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:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
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 and children 12 years and over	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.
children under 12 years	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

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?

call 1-855-274-4122

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

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 Tablets Bottle)

CVSHealth_®Tablets

NDC 69842-635-07

8HR Muscle

Aches & Pain

ACETAMINOPHEN

EXTENDED-RELEASE

TABLETS USP, 650 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

24 EXTENDED-RELEASE

TABLETS 650 mg EACH

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

CVS Health_®                                               Compare to the active ingredient in

                                                                     Tylenol^® 8HR Muscle Aches & Pain*



                                                                                         Tablets

NDC 69842-635-07

8HR Muscle Aches & Pain

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS USP, 650 mg

Pain Reliever/Fever Reducer

For up to 8 hours of relief of minor

muscle aches & pain

Contains No Aspirin

24 EXTENDED-RELEASE

TABLETS 650 mg EACH

DO NOT USE WITH

OTHER MEDICINES

CONTAINING

ACETAMINOPHEN

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
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 and children 12 years and over	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.
children under 12 years	do not use

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?

call 1-855-274-4122

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

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 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle))

CVSHealth_®Tablets

NDC 69842-635-07

8HR Muscle

Aches & Pain

ACETAMINOPHEN

EXTENDED-RELEASE

TABLETS USP, 650 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

24 EXTENDED-RELEASE

TABLETS 650 mg EACH

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

CVS Health_®                                               Compare to the active ingredient in

                                                                     Tylenol^® 8HR Muscle Aches & Pain*



                                                                                         Tablets

NDC 69842-635-07

8HR Muscle Aches & Pain

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS USP, 650 mg

Pain Reliever/Fever Reducer

For up to 8 hours of relief of minor

muscle aches & pain

Contains No Aspirin

24 EXTENDED-RELEASE

TABLETS 650 mg EACH

DO NOT USE WITH

OTHER MEDICINES

CONTAINING

ACETAMINOPHEN

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: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold 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 and children 12 years and over 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. children under 12 years 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": "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? call 1-855-274-4122 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com ® 1-800-SHOP CVS 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 Tablets Bottle)": "CVSHealth ® Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 24 EXTENDED-RELEASE TABLETS 650 mg EACH", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton)": "CVS Health ® Compare to the active ingredient in Tylenol ® 8HR Muscle Aches & Pain* Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours of relief of minor muscle aches & pain Contains No Aspirin 24 EXTENDED-RELEASE TABLETS 650 mg EACH DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information