0220k- Major

0220k- Major
SPL v4
SPL
SPL Set ID 780aad35-d0f1-44b1-e053-2991aa0af9a7
Route
ORAL
Published
Effective Date 2024-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Stearic Acid Sodium Starch Glycolate Type A Potato Starch, Corn Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: CPC;220 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-23

Description

Active ingredient (in each tablet) Acetaminophen 325 mg


Medication Information

Warnings and Precautions

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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.

Description

Active ingredient (in each tablet) Acetaminophen 325 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 42229-5

Keep this carton for complete product information

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 51727-6

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Section 51945-4

NDC 0904-6773-61

MAJOR

Unit Dose

Acetaminophen

Regular Strength Tablets

325 mg

100 Tablets

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/ Fever reducer

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

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
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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

Other Information

Store in a dry place at 15˚ - 30˚C (59˚ - 86˚F).

Questions Or Comments?

1-800-231-4670


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Warnings and Precautions (34071-1)

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 42229-5 (42229-5)

Keep this carton for complete product information

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 51727-6 (51727-6)

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Section 51945-4 (51945-4)

NDC 0904-6773-61

MAJOR

Unit Dose

Acetaminophen

Regular Strength Tablets

325 mg

100 Tablets

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

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

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
Overdose Warning (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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

Other Information (Other information)

Store in a dry place at 15˚ - 30˚C (59˚ - 86˚F).

Questions Or Comments? (Questions or comments?)

1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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