ACETAMINOPHEN - acetaminophen tablet, extended release 
Aurohealth LLC

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Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

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

 

adults and children 12 years and over
  • 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.
children under 12 years
  • do not use

Other information

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
279 Princeton-Hightstown Road
East Windsor, NJ 08520

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 58602-873-36
                    2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR    MUSCLE ACHES & PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

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



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

AUROHEALTH
NDC 58602-873-36

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

8 HOUR             MUSCLE ACHES & PAIN


Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For Up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

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


ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-873
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (White to Off-White) Scoreno score
ShapeCAPSULE (Caplet) Size19mm
FlavorImprint Code I;06
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-873-361 in 1 CARTON12/27/2021
1250 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-873-071 in 1 CARTON12/27/2021
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-873-141 in 1 CARTON12/27/2021
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-873-211 in 1 CARTON12/27/2021
4100 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-873-291 in 1 CARTON12/27/2021
5150 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-873-34200 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
7NDC:58602-873-35225 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
8NDC:58602-873-67290 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
9NDC:58602-873-76325 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
10NDC:58602-873-40500 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
11NDC:58602-873-411000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
12NDC:58602-873-94100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
13NDC:58602-873-44400 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20722912/27/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-873) , MANUFACTURE(58602-873)

Revised: 1/2024
Document Id: 144490f4-f2a5-4c6d-abf2-5e7ee65d66d7
Set id: f076fd33-9eaf-49b9-b0ee-6a349567c5ff
Version: 4
Effective Time: 20240124
 
Aurohealth LLC