SPL v2
SPL
SPL Set ID bc03fa56-8880-4bbd-81a0-91853fecdd4e
Route
ORAL
Published
Effective Date 2023-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Ammonia Ferrosoferric Oxide Silicon Dioxide Fd&c Blue No. 1 Fd&c Red No. 3 Fd&c Red No. 40 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Starch, Corn Propylene Glycol Shellac Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: J;1 Shape: capsule Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-07
Description

Active ingredient (in each gelcap) Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each gelcap) Acetaminophen USP 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • 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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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 gelcap)



Acetaminophen USP 500 mg

Other Information
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing
Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Package Label Principal Display Panel 500 Mg (100 Gelcaps Container Label)

AUROHEALTH

NDC 58602-745-21

FOR ADULTS

EXTRA STRENGTH

Acetaminophen Gelcaps 500 mg

Pain Reliever, Fever Reducer

Rapid Release Gels

100 GELCAPS

500 mg each







Package Label Principal Display Panel 500 Mg (100 Gelcaps Container Carton)

AUROHEALTH

Compare to the active ingredient in

Extra Strength Tylenol ®Rapid Release Gels †

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

NDC 58602-745-21

FOR ADULTS

EXTRA STRENGTH

Acetaminophen

Gelcaps 500 mg

Pain Reliever, Fever Reducer

Rapid Release Gels



Actual Size

100 GELCAPS

500 mg each





Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • 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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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 gelcap)



Acetaminophen USP 500 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments? (Questions or comments?)

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

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

Package Label Principal Display Panel 500 Mg (100 Gelcaps Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Label))

AUROHEALTH

NDC 58602-745-21

FOR ADULTS

EXTRA STRENGTH

Acetaminophen Gelcaps 500 mg

Pain Reliever, Fever Reducer

Rapid Release Gels

100 GELCAPS

500 mg each







Package Label Principal Display Panel 500 Mg (100 Gelcaps Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Carton))

AUROHEALTH

Compare to the active ingredient in

Extra Strength Tylenol ®Rapid Release Gels †

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

NDC 58602-745-21

FOR ADULTS

EXTRA STRENGTH

Acetaminophen

Gelcaps 500 mg

Pain Reliever, Fever Reducer

Rapid Release Gels



Actual Size

100 GELCAPS

500 mg each





Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.483139 · Updated: 2026-03-14T23:01:55.379030