DailyMed - ACETAMINOPHEN tablet, extended release (2024)

  • Label RSS
  • NDC Code(s): 58602-730-07, 58602-730-14, 58602-730-21, 58602-730-28, view more

    58602-730-29, 58602-730-34, 58602-730-35, 58602-730-36, 58602-730-40, 58602-730-41, 58602-730-44, 58602-730-67, 58602-730-76, 58602-730-94

  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2024

If you are a consumer or patient please visit this version.

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)

View All Sections

  • Drug Facts

    Active ingredient (in each extended-release tablet)

    Acetaminophen USP 650 mg

  • Purpose
  • 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
    • Meets USP dissolution test 3
  • 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 (225 Tablets Bottle)

    AUROHEALTH
    TO OPEN: 1. PUSH DOWN NDC 58602-730-28
    2. TURN CAP
    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN
    8 HOUR ARTHRITIS PAIN
    Acetaminophen
    Extended-Release
    Tablets USP
    650 mg
    Pain Reliever/Fever Reducer
    For the Temporary Relief of
    Minor Arthritis Pain
    225 Extended-release tablets

    DailyMed - ACETAMINOPHEN tablet, extended release (3)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton)

    AUROHEALTH
    NDC 58602-730-28
    *Compare to the Active
    Ingredient in Tylenol®
    8 HR Arthritis Pain

    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN
    8 HOUR ARTHRITIS PAIN
    Acetaminophen
    Extended-Release
    Tablets USP
    650 mg
    Pain Reliever/Fever Reducer
    For the Temporary Relief of
    Minor Arthritis Pain
    225 Extended-release tablets

    DailyMed - ACETAMINOPHEN tablet, extended release (4)

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-730
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650mg
    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:58602-730-361 in 1 CARTON11/09/2016
    1250 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-730-071 in 1 CARTON08/11/2018
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-730-141 in 1 CARTON08/11/2018
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-730-211 in 1 CARTON08/11/2018
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-730-29150 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    6NDC:58602-730-34200 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    7NDC:58602-730-35225 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    8NDC:58602-730-67290 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    9NDC:58602-730-76325 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    10NDC:58602-730-40500 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    11NDC:58602-730-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2018
    12NDC:58602-730-94100 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    13NDC:58602-730-44400 in 1 BOTTLE; Type 0: Not a Combination Product01/11/2021
    14NDC:58602-730-281 in 1 CARTON12/29/2021
    14225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20722911/09/2016

    Labeler -Aurohealth LLC(078728447)

    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-730) , MANUFACTURE(58602-730)

View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

View Labeling Archives for this drug

ACETAMINOPHEN tablet, extended release

Number of versions: 9

Published Date (What is this?) Version Files
Jan 26, 2024 9 (current) download
Jun 8, 2023 8 download
Apr 4, 2023 7 download
Dec 31, 2021 6 download
Jan 19, 2021 5 download
Apr 30, 2020 4 download
Jan 3, 2020 3 download
Sep 26, 2019 2 download
Nov 14, 2016 1 download

RxNorm

ACETAMINOPHEN tablet, extended release

RxCUI RxNorm NAME RxTTY
1 1148399 acetaminophen 650 MG 8HR Extended Release Oral Tablet PSN
2 1148399 8 HR acetaminophen 650 MG Extended Release Oral Tablet SCD
3 1148399 8 HR APAP 650 MG Extended Release Oral Tablet SY
4 1148399 acetaminophen 650 MG 8 HR Extended Release Oral Tablet SY

Get Label RSS Feed for this Drug

ACETAMINOPHEN tablet, extended release

To receive this label RSS feed

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=179c221d-c099-400c-b3ac-124e26947620

To receive all DailyMed Updates for the last seven days

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/rss.cfm

What will I get with the DailyMed RSS feed?

DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.

How to discontinue the RSS feed

If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?


Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

NDC Codes

ACETAMINOPHEN tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 58602-730-07
2 58602-730-14
3 58602-730-21
4 58602-730-28
5 58602-730-29
6 58602-730-34
7 58602-730-35
8 58602-730-36
9 58602-730-40
10 58602-730-41
11 58602-730-44
12 58602-730-67
13 58602-730-76
14 58602-730-94
DailyMed - ACETAMINOPHEN tablet, extended release (2024)
Top Articles
Latest Posts
Recommended Articles
Article information

Author: Carmelo Roob

Last Updated:

Views: 5849

Rating: 4.4 / 5 (65 voted)

Reviews: 88% of readers found this page helpful

Author information

Name: Carmelo Roob

Birthday: 1995-01-09

Address: Apt. 915 481 Sipes Cliff, New Gonzalobury, CO 80176

Phone: +6773780339780

Job: Sales Executive

Hobby: Gaming, Jogging, Rugby, Video gaming, Handball, Ice skating, Web surfing

Introduction: My name is Carmelo Roob, I am a modern, handsome, delightful, comfortable, attractive, vast, good person who loves writing and wants to share my knowledge and understanding with you.