ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG - acetaminophen tablet, extended release 
MARKSANS PHARMA LIMITED

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Arthritis Pain Relief
Acetaminophen Extended-Release Tablets USP, 650 mg

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain


Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

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

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

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 and children 12 years and over 
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split, or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor 
 children under 12 years
  •  ask a doctor.

Other information



Inactive ingredients

carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments ?
Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

PRINCIPAL DISPLAY PANEL

NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain
24 count carton label


aceta-24s-carton


NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
24 count bottle label


aceta-24s-label


NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
100 count carton label


aceta-100s-carton


NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
100 count bottle label


aceta-100s-label


NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
225 count carton label


aceta-225s-carton


NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
225 count bottle label


aceta-225s-label


NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
290 count carton label


 

aceta-290s-carton

NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
290 count bottle label


 

aceta-290s-label


NDC 25000-071-45
Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
400 count bottle label


aceta-400s-label


NDC 25000-108-02
Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
24 count carton label


aceta-musclepain-24s-carton


NDC 25000-108-02
Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
24 count bottle label


aceta-musclepain-24s-label


NDC 25000-108-08
Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
100 count carton label


aceta-musclepain-100s-carton


NDC 25000-108-08
Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
100 count bottle label


aceta-muscle-100s-label


ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-071
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)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
Product Characteristics
ColorWHITE (White to off white) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-071-021 in 1 CARTON09/02/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:25000-071-081 in 1 CARTON09/02/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-071-101 in 1 CARTON09/02/2021
3225 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:25000-071-111 in 1 CARTON09/02/2021
4290 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:25000-071-45400 in 1 BOTTLE; Type 0: Not a Combination Product09/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21548609/02/2021
ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-108
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)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-108-021 in 1 CARTON10/14/2022
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:25000-108-081 in 1 CARTON10/14/2022
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21548610/14/2022
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-071, 25000-108)

Revised: 10/2023
Document Id: 9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
Set id: d973a910-5fe0-4a85-884d-2c3987836691
Version: 5
Effective Time: 20231017
 
MARKSANS PHARMA LIMITED