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

Acetaminophen Extended-Release Tablets, 650 mg by

Drug Labeling and Warnings

Acetaminophen Extended-Release Tablets, 650 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

• 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.

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

• temporarily relieves minor aches and pains due to:
  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps
  • headache
  • the common cold

• temporarily reduces fever

Warnings

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

• more than 6 caplets 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 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

• store between 20-25°C (68-77°F)
• The FDA approved Dissolution methods differ from USP
• do not use if carton is opened. Do not use if foil inner seal is broken or missing

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

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

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

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

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

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

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

 

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

 

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

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

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

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-071
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
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
Color	WHITE (White to off white)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-071-02	1 in 1 CARTON	09/02/2021
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-071-08	1 in 1 CARTON	09/02/2021
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-071-10	1 in 1 CARTON	09/02/2021
3		225 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 25000-071-11	1 in 1 CARTON	09/02/2021
4		290 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 25000-071-45	400 in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215486	09/02/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-108
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
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
Color	WHITE (white to off white)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-108-02	1 in 1 CARTON	10/14/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-108-08	1 in 1 CARTON	10/14/2022
2		100 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	ANDA215486	10/14/2022

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-071, 25000-108)