Label: ACETAMINOPHEN tablet, extended release
- NDC Code(s): 21130-108-07, 21130-108-35
- Packager: Better Living Brands, 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
-
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
- 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
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASONTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com
MADE IN INDIA
CODE: TS/DRUGS/22/2009 -
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle)
TO OPEN:
1. PUSH DOWN
2. TURN CAP
Signaturte
Care®
Quality
Guaranteed
DO NOT USE
WITH OTHER
MEDICINES
CONTAINING
ACETAMINOPHEN
8 HOUR NDC 21130-108-35
ARTHRITIS
PAIN
RELIEVER
ACETAMINOPHEN
Extended-Release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the temporary relief of 225
minor arthritis pain Extended-Release
Tablets
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton)
Compare to Tylenol®8HR Arthritis Pain
active ingredient*
NDC 21130-108-35
Signature
Care®
Quality Guaranteed
DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN
8 HOUR
ARTHRITIS
PAIN RELIEVER
ACETAMINOPHEN Actual Size
Extended-Release 06
Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the temporary relief 225
of minor arthritis pain Extended-release
tablets
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-108 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:21130-108-07 1 in 1 CARTON 06/24/2022 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21130-108-35 1 in 1 CARTON 06/24/2022 2 225 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 06/24/2022 Labeler - Better Living Brands, LLC (009137209) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(21130-108) , MANUFACTURE(21130-108)