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  5. Label Information: Aurophen Extra Strength For Adults

FDA Label for Aurophen Extra Strength For Adults

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 MG (250 CAPLETS BOTTLE)
    16. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 MG (500 CAPLETS BOTTLE)

Aurophen Extra Strength For Adults Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredient (in each caplet)

Acetaminophen USP 500 mg


Purpose



Pain reliever/fever reducer


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.


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 You Have



liver disease


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin


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.


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 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, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, titanium dioxide.


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
Made in India

Code: TS/DRUGS/16/2014


Package Label-Principal Display Panel 500 Mg (250 Caplets Bottle)



Healthy Living™
NDC 58602-771-36
Compare to the active ingredient
in Tylenol ® Extra strength Caplets* 
See Warnings Information & Directions
EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin
250
Caplets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (250 Caplets Bottle) - acetaminophen fig1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (250 Caplets Bottle) - acetaminophen fig1



Package Label-Principal Display Panel 500 Mg (500 Caplets Bottle)



Healthy Living™
NDC 58602-771-40
Compare to the active ingredient
in Tylenol ® Extra strength Caplets* 
See Warnings Information & Directions
EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin
500
Caplets


* Please review the disclaimer below.