Cardinal Leader Acetaminophen Extended Release Tablets Usp, 650 Mg Muscle Aches And Pain

Cardinal Leader Acetaminophen Extended Release Tablets Usp, 650 Mg Muscle Aches And Pain
SPL v2
SPL
SPL Set ID 331f4bd1-1303-cc48-e063-6394a90a74d3
Route
ORAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Magnesium Stearate Carnauba Wax Microcrystalline Cellulose Povidone Triacetin Sodium Starch Glycolate Type A Starch, Corn Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 71 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2025-06-15
Description

Drug Facts

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:

  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps
  • headache
  • the common cold

temporarily reduces fever

Dosage and Administration

Directions

Do not take more than directed.

See overdose warning

adults and children 12 years and over
  • 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
children under 12 years
  • do not use

Description

Drug Facts

Section 34088-5

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 50565-1

Keep out of reach of children.

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, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-632-6900

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

Section 60561-8

Other information

  • store between 20-25ºC (68-77ºF)
  • The FDA approved dissolution methods differ from USP
Drug Facts

Drug Facts

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

Do not take more than directed.

See overdose warning

adults and children 12 years and over
  • 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
children under 12 years
  • do not use

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 34088-5 (34088-5)

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 50565-1 (50565-1)

Keep out of reach of children.

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, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

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

Section 60561-8 (60561-8)

Other information

  • store between 20-25ºC (68-77ºF)
  • The FDA approved dissolution methods differ from USP
Drug Facts

Drug Facts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:19.617681 · Updated: 2026-03-14T23:09:01.566522