Aurophen extra strength for adults tablet

Drug facts

Active ingredient (in each caplet)

Acetaminophen USP500 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 areallergic 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 than6 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 25C (68 to 77F)
  • 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

Ingredients and appearance - Product information

Aurophen extra strength for adults tablet- Acetaminophen

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-755
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (White to off White) Shape CAPSULE (Biconvex)
Size 18 mm Score 1
Imprint Code N79

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-755)

Package label-principal display panel 500 mg (100 caplets bottle)

AUROHEALTH

NDC 58602-755-21

Compare to the active ingredient
in Tylenol ®Extra strength Caplets *


See Warnings Information & Directions

EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen
Caplets500 mg
Pain reliever/Fever reducer
Contains No Aspirin
100
Caplets