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- 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)
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- 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
- temporarily relieves minor aches and pains due to:
- 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 08520Made 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 - 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 - INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct 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 650mg 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 12 NDC:58602-730-94 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2020 13 NDC:58602-730-44 400 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2021 14 NDC:58602-730-28 1 in 1 CARTON 12/29/2021 14 225 in 1 BOTTLE; Type 0: Not a Combination Product 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)
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More Info on this Drug
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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 |
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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 |