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

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.

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
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

Other Information

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

Inactive Ingredients

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

Description

Active ingredient (in each capsule) Acetaminophen 500 mg

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

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

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.

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

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.

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
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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

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

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

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.

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