Cardinal-leader Acetaminophen Extended-release Tablets Usp, 650 Mg

Cardinal-leader Acetaminophen Extended-release Tablets Usp, 650 Mg
SPL v3
SPL
SPL Set ID 331f907a-0fb6-e23d-e063-6394a90a2db1
Route
ORAL
Published
Effective Date 2025-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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:

- minor pain of arthritis

- muscular aches n backache

- premenstrual and menstrual cramps

- the common cold n headache

- 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

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 42229-5

Drug Facts

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 1-877-290-4008

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

Section 60561-8

Other information

  • store between 20-25°C (68-77°F)
  • The FDA approved dissolution methods differ from USP

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:

- minor pain of arthritis

- muscular aches n backache

- premenstrual and menstrual cramps

- the common cold n headache

- 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 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 42229-5 (42229-5)

Drug Facts

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 1-877-290-4008

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

Section 60561-8 (60561-8)

Other information

  • store between 20-25°C (68-77°F)
  • The FDA approved dissolution methods differ from USP

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.923230 · Updated: 2026-03-14T23:09:06.809873