Label: ACETAMINOPHEN tablet, extended release
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NDC Code(s):
58602-873-07,
58602-873-14,
58602-873-21,
58602-873-29, view more58602-873-34, 58602-873-35, 58602-873-36, 58602-873-40, 58602-873-41, 58602-873-44, 58602-873-67, 58602-873-76, 58602-873-94
- 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)
- Drug Facts
- Purpose
- Uses
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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
- Keep out of reach of children.
-
Directions
- do not take more than directed (see overdose warning).
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
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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 Tablets Container Carton)
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-873 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:58602-873-36 1 in 1 CARTON 12/27/2021 1 250 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-873-07 1 in 1 CARTON 12/27/2021 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-873-14 1 in 1 CARTON 12/27/2021 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-873-21 1 in 1 CARTON 12/27/2021 4 100 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-873-29 1 in 1 CARTON 12/27/2021 5 150 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-873-34 200 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 7 NDC:58602-873-35 225 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 8 NDC:58602-873-67 290 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 9 NDC:58602-873-76 325 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 10 NDC:58602-873-40 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 11 NDC:58602-873-41 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 12 NDC:58602-873-94 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 13 NDC:58602-873-44 400 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207229 12/27/2021 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-873) , MANUFACTURE(58602-873)