ACETAMINOPHEN tablet, extended release

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Better Living Brands, LLC, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

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:
BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle)

8HR               NDC: 21130-108-35

TO OPEN:
1. PUSH DOWN
2. TURN CAP

Signature
SELECT®

ARTHRITIS PAIN
RELIEVER
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS USP, 650 mg

Pain Reliever/Fever Reducer

For the temporary relief of minor
arthritis pain

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN 

225  Extended-release tablets      
    

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

8HR

COMPARE TO
Tylenol® 8HR Arthritis Pain Active Ingredient*

NDC: 21130-108-35

Signature
SELECT®

ARTHRITIS PAIN
RELIEVER
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS USP, 650 mg
Pain Reliever/Fever Reducer
For the temporary relief of minor arthritis pain

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

06
Actual Size

225 Extended-release tablets
 

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product 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)