Aurophen Regular Strength Tablet
FDA Label NDC 58602-754

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Aurophen Regular Strength (NDC 58602-754). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 325 mg

Purpose

Pain reliever/fever reducer

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

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

Ask A Doctor Before Use If The User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If The User Is

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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)
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)

    •  

    adults and children 12 years and over
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
    children 6-11 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 years
    		ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or seal under cap is torn or missing.

Inactive Ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, sodium starch glycolate, talc

Questions Or Comments?

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: Aurohealth LLC.
2572 Brunswick Pike, Lawrenceville, NJ 08648

Package Label-Principal Display Panel 325 Mg (100 Tablets Bottle)

AUROHEALTH

NDC 58602-754-21

Compare to the active ingredient in Tylenol ® Regular Strength tablets*
See Warnings Information & Directions
REGULAR STRENGTH
AUROPHEN
Acetaminophen Tablets 325 mg
Pain reliever/Fever reducer
100 Tablets

Package Label-principal Display Panel 325 mg (100 Tablets Bottle) (Aurophen Fig1)

Package Label-principal Display Panel 325 mg (100 Tablets Bottle) (Aurophen Fig1)

* Please review the disclaimer below.