ACETAMINOPHEN tablet, extended release

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • muscular aches
  • backache
  • premenstrual and menstrual cramps
  • the common cold
  • headache
  • toothache
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 tablets in 24 hours, which is the maximum daily amount
• 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:

• take 2 tablets every 8 hours with water
• swallow whole; do not crush, chew, split or dissolve
• do not take more than 6 tablets in 24 hours
• do not use for more than 10 days unless directed by a doctor.

Under 18 years of age:

• ask a doctor

Other information

• store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
• do not use if carton is opened or foil inner seal is broken
• USP Dissolution test is pending 

Inactive ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments? 
 call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)

AUROHEALTH
TO OPEN: 1. PUSH DOWN         NDC: 58602-730-36
                   2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
250 Extended-release tablets

          

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)

AUROHEALTH
NDC: 58602-730-36
*Compare to the Active
Ingredient in Tylenol®
8 HR Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
250 Extended-release tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-730
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE (White to Off-White)	Score	no score
Shape	CAPSULE (Caplet)	Size	19mm
Flavor		Imprint Code	I;06
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-730-36	1 in 1 CARTON	11/09/2016
1		250 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-730-07	1 in 1 CARTON	08/11/2018
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-730-14	1 in 1 CARTON	08/11/2018
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-730-21	1 in 1 CARTON	08/11/2018
4		100 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-730-29	150 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
6	NDC: 58602-730-34	200 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
7	NDC: 58602-730-35	225 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
8	NDC: 58602-730-67	290 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
9	NDC: 58602-730-76	325 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
10	NDC: 58602-730-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018
11	NDC: 58602-730-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207229	11/09/2016

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-730) , MANUFACTURE(58602-730)