0617 - Major

0617 - Major
SPL v8
SPL
SPL Set ID 34a95450-3f04-4de4-9113-73e7bd5724a0
Route
ORAL
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CPC;617 Shape: capsule Color: white Color: red Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1997-12-22 Until 2017-04-30
Description

Active ingredient (in each capsule) Acetaminophen 500 mg

Medication Information

Description

Active ingredient (in each capsule) Acetaminophen 500 mg

Uses

Temporarily relieves fever and minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • toothache
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
Section 42229-5

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

TAMPER EVIDENT: DO NOT USE IF CAPSULE BAND OR PRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 51945-4

Major

NDC 0904-1987-60

extra strength

Mapap®

acetaminophen 500 mg each

pain reliever / fever reducer

aspirin free

100 capsules

Section 55105-1

Purpose

Pain reliever/fever reducer

Warnings

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

  • more than 6 capsules 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 of age and over:

  • take 2 capsules every 6 hours while symptoms last
  • do not take more than 6 capsules in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

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
Drug Facts

Active ingredient (in each capsule)



Acetaminophen 500 mg

Other Information

store in a dry place at 15° – 30°C (59° – 86°F).

Overdose Warning:

In the 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.

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide

Questions Or Comments?

Call 1-800-231-4670

Monday-Friday 9AM-5PM ET

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.

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

Structured Label Content

Uses

Temporarily relieves fever and minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • toothache
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
Section 42229-5 (42229-5)

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

TAMPER EVIDENT: DO NOT USE IF CAPSULE BAND OR PRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 51945-4 (51945-4)

Major

NDC 0904-1987-60

extra strength

Mapap®

acetaminophen 500 mg each

pain reliever / fever reducer

aspirin free

100 capsules

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Warnings

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

  • more than 6 capsules 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 of age and over:

  • take 2 capsules every 6 hours while symptoms last
  • do not take more than 6 capsules in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

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
Drug Facts

Active ingredient (in each capsule)



Acetaminophen 500 mg

Other Information (Other information)

store in a dry place at 15° – 30°C (59° – 86°F).

Overdose Warning: (Overdose warning:)

In the 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.

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-231-4670

Monday-Friday 9AM-5PM ET

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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.684293 · Updated: 2026-03-14T23:13:16.476899