NDC 25000-071 Acetaminophen Extended-release Tablets, 650 Mg

Acetaminophen

NDC Product Code 25000-071

NDC CODE: 25000-071

Proprietary Name: Acetaminophen Extended-release Tablets, 650 Mg What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
71
Score: 1

NDC Code Structure

NDC 25000-071-02

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC 25000-071-08

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC 25000-071-10

Package Description: 1 BOTTLE in 1 CARTON > 225 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC 25000-071-11

Package Description: 1 BOTTLE in 1 CARTON > 290 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Acetaminophen Extended-release Tablets, 650 Mg with NDC 25000-071 is a a human over the counter drug product labeled by Marksans Pharma Limited. The generic name of Acetaminophen Extended-release Tablets, 650 Mg is acetaminophen. The product's dosage form is tablet, extended release and is administered via oral form.

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Acetaminophen Extended-release Tablets, 650 Mg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marksans Pharma Limited
Labeler Code: 25000
FDA Application Number: ANDA215486 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-02-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Acetaminophen Extended-release Tablets, 650 Mg Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothachetemporarily reduces fever

Warnings

  • Liver warning This product contains acetaminophen. Severe liver damage may occur if you takemore than 6 caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product.Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness 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) Adultstake 2 caplets every 8 hours with waterswallow whole; do not crush, chew, split or dissolvedo not take more than 6 caplets in 24 hoursdo not use for more than 10 days unless directed by a doctor  Under 18 years of age  ask a doctorOther informationstore between 20-25°C (68-77°F)The FDA approved Dissolution methods differ from USPdo 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, triacetinQuestions or comments ? Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

* Please review the disclaimer below.