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

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 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

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.

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



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

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.

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

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

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.

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



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

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.

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

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