Acetaminophen Extended Release Tablets 650 Mg - Arthritis Pain Walgreens

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Hypromellose, Unspecified Starch, Corn Titanium Dioxide Carnauba Wax Hydroxyethyl Cellulose, Unspecified Povidone K30 Magnesium Stearate Sodium Starch Glycolate Type A Microcrystalline Cellulose Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 71 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2022-09-28

Medication Information

Warnings and Precautions

Warnings

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

• more than 6 caplets 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.

Indications and Usage

Uses

• temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o premenstrual and menstrual cramps

o the common cold

o headache

o toothache

• temporarily reduces fever

Dosage and Administration

Directions

Do not take more than directed
See overdose warning

adults	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

Description

Active ingredient (in each caplet) Acetaminophen 650 mg

Section 44425-7

Other information

• store between 20-25ºC (68-77ºF)

• The FDA approved Dissolution methods differ from USP

Section 50565-1

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.

Section 50566-9

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

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

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

Section 51727-6

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 650 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o premenstrual and menstrual cramps

o the common cold

o headache

o toothache

• temporarily reduces fever

Dosage and Administration (34068-7)

Directions

Do not take more than directed
See overdose warning

adults	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

• more than 6 caplets 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.

Section 44425-7 (44425-7)

Other information

• store between 20-25ºC (68-77ºF)

• The FDA approved Dissolution methods differ from USP

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 650 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • temporarily relieves minor aches and pains due to: o minor pain of arthritis o muscular aches o backache o premenstrual and menstrual cramps o the common cold o headache o toothache • temporarily reduces fever", "34068-7": "Directions Do not take more than directed See overdose warning adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor", "34071-1": "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets 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.", "44425-7": "Other information • store between 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP", "50565-1": "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.", "50566-9": "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if you have liver disease", "50570-1": "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", "51727-6": "Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin", "53413-1": "Questions or comments? Call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain reliever/fever reducer", "55106-9": "Active ingredient (in each caplet) Acetaminophen 650 mg"}