NDC 23155-202 Acetamiophen

Acetaminophen

NDC Product Code 23155-202

NDC 23155-202-01

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

NDC 23155-202-18

Package Description: 20000 TABLET, EXTENDED RELEASE in 1 CONTAINER

NDC 23155-202-64

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

NDC 23155-202-65

Package Description: 1 BOTTLE in 1 CARTON > 750 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Acetamiophen with NDC 23155-202 is a a human over the counter drug product labeled by Heritage Pharmaceuticals Inc.. The generic name of Acetamiophen is acetaminophen. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Heritage Pharmaceuticals Inc.

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.

Acetamiophen 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.

  • ACETAMINOPHEN 650 mg/1

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.

  • HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • POVIDONES (UNII: FZ989GH94E)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

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.
  • 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: Heritage Pharmaceuticals Inc.
Labeler Code: 23155
FDA Application Number: ANDA207035 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: 06-01-2018 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Acetamiophen 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

Other

Drug FactsActive Ingredients (In each caplet)Active ingredient (in each caplet)                                                          Purpose Acetaminophen 650 mg                               Pain reliever/fever reducer

Otc - Purpose

Drug FactsActive ingredient (in each caplet)Acetaminophen 650mg ....................... Pain reliever/fever reducer.

Uses

  • Temporarily relieves minor aches and pain due to:muscular achesbackacheminor pain of arthritistoothachepremenstrual and menstrual crampsheadachethe common coldtemporarily 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 reddeningblistersrash.If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • With any other drug containing acetaminophen (prescription or non-prescription). 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.

Otc - Ask Doctor

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

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 if present.These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poision Control of 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 of 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 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 doctorChildren under 12 years:do not use

Other Information

  • Store between 20-25°C (68-77°F)do not use if foil inner seal imprinted with "SAFETY SEAL" is broken or missing.

Inactive Ingredients

Hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.

* Please review the disclaimer below.