AUROPHEN EXTRA STRENGTH FOR ADULTS- acetaminophen tablet

Aurophen Extra Strength for Adults by

Drug Labeling and Warnings

Aurophen Extra Strength for Adults by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)
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 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

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
AUROPHEN
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
Contains No Aspirin
100 Caplets

INGREDIENTS AND APPEARANCE

AUROPHEN EXTRA STRENGTH FOR ADULTS 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-755
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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)	Score	no score
Shape	CAPSULE (Biconvex)	Size	18mm
Flavor		Imprint Code	N79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-755-07	1 in 1 CARTON	02/26/2016
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-755-12	1 in 1 CARTON	02/26/2016
2		40 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-755-14	1 in 1 CARTON	02/26/2016
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-755-21	1 in 1 CARTON	02/26/2016
4		100 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-755-29	150 in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2016
6	NDC: 58602-755-34	200 in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2016
7	NDC: 58602-755-35	225 in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2016
8	NDC: 58602-755-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/26/2016

Labeler - Aurohealth LLC (078728447)

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