ACETAMINOPHEN- acetaminophen tablet 
BluePoint Laboratories

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Acetaminophen Extended-Release Tablets, USP 650mg

Drug Facts

Active Ingredient (in each extended release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before ue 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

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:

Under 18 years of age:

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

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.

For BluePoint Laboratories

Rev: 03/2021

M.L. No.: 22/MN/AP/2009/F/R

Package Label - Principal Display Panel

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00

Carton

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00

Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-495
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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:68001-495-001 in 1 CARTON04/30/2021
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20722904/30/2021
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Ltd650381903analysis(68001-495) , manufacture(68001-495)

Revised: 9/2023
Document Id: 04895d7d-bcce-be52-e063-6294a90a3c13
Set id: c065c531-88f5-0930-e053-2a95a90ae861
Version: 2
Effective Time: 20230904
 
BluePoint Laboratories