1092 - heb - 2019-1004

1092 - heb - 2019-1004
SPL v5
SPL
SPL Set ID 0863aeaa-15ec-4c67-ba79-4dad54555bd2
Route
oral
Published
Effective Date 2019-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
polysorbate 80 povidone starch, pregelatinized corn sodium starch glycolate type a corn stearic acid titanium dioxide acesulfame potassium fd&c red no. 40 aluminum oxide fd&c yellow no. 6 hypromelloses polyethylene glycol, unspecified

Identifiers & Packaging

Pill Appearance
Imprint: A92 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2013-02-01
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Active Ingredient

Acetaminophen 500 mg

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

Pain reliever/fever reducer

Directions
adults and children 12 years and over
  • take 2 tablets every 6 hours while symptoms last
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • ask a doctor
Other Information
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Description

Drug Facts

Principal Display Panel

Compare to Tylenol(R) Extra Strength Coated Tablets active ingredient

HEB

NDC 37808-792-03

Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

For Adults

Sweet Coated

50 COATED TABLETS

Section 42229-5

Drug Facts

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 53414-9

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

Liver Warning

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using 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.

Questions Or Comments?

1-844-705-4384

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.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

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

Pain reliever/fever reducer

Directions
adults and children 12 years and over
  • take 2 tablets every 6 hours while symptoms last
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • ask a doctor
Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Tylenol(R) Extra Strength Coated Tablets active ingredient

HEB

NDC 37808-792-03

Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

For Adults

Sweet Coated

50 COATED TABLETS

Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

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

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
Allergy Alert (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.

Liver Warning (Liver warning)

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using 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.

Questions Or Comments? (Questions or comments?)

1-844-705-4384

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:55.228566 · Updated: 2026-03-14T23:04:16.644897