049f0e45-500c-e964-e063-6294a90a7850

SPL v1
SPL
SPL Set ID 049f0e45-500c-e964-e063-6294a90a7850
Route
oral
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
povidone k30 starch, corn palmitostearic acid

Identifiers & Packaging

Pill Appearance
Imprint: N79 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
otc monograph not final active Since 2021-10-18
Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Medication Information

Warnings

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

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 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
  • do not take more than directed (see overdose warning)
adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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° to 25°C (68° to 77°F)
  • do not use if printed foil seal under cap is torn or missing.
Inactive Ingredients

povidone, pregelatinized starch (maize), stearic acid.

Description

Active ingredient (in each caplet) Acetaminophen USP 500 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
Drug Facts

Active ingredient (in each caplet)



Acetaminophen USP 500 mg

Questions Or Comments?

call 1-855-274-4122



Distributed by:

Aurohealth LLC.

279 Princeton- Hightstown Road,

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/16/2014

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.

Keep Out of Reach of Children.

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.

Ask A Doctor Before Use If You Have

liver disease

Package Label Principal Display Panel

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 4,000 mg of acetaminophen in 24 hours
  • 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 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
  • do not take more than directed (see overdose warning)
adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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° to 25°C (68° to 77°F)
  • do not use if printed foil seal under cap is torn or missing.
Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch (maize), stearic acid.

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 caplet)



Acetaminophen USP 500 mg

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122



Distributed by:

Aurohealth LLC.

279 Princeton- Hightstown Road,

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/16/2014

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

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

liver disease

Package Label Principal Display Panel (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)

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: 2026-02-15T12:01:13.309739 · Updated: 2026-03-14T23:01:19.203951