NDC 61919-860 Acetaminophen ER

Acetaminophen

NDC Product Code 61919-860

NDC Code: 61919-860

Proprietary Name: Acetaminophen ER 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
COR116
Score: 1

NDC Code Structure

  • 61919 - Directrx
    • 61919-860 - Acetaminophen

NDC 61919-860-71

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Acetaminophen ER with NDC 61919-860 is a a human over the counter drug product labeled by Directrx. The generic name of Acetaminophen ER is acetaminophen. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Directrx

Dosage Form: Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

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 ER 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.

  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: Directrx
Labeler Code: 61919
FDA Application Number: ANDA076200 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: 04-26-2019 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.

Acetaminophen ER Product Label Images

Acetaminophen ER 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 Facts

Distributed by:

Ohm Laboratories Inc.

North Brunswick, NJ 0890

Otc - Active Ingredient

Acetaminophen USP, 650 mg

Otc - Purpose

Pain reliever/fever reducer

Indications & Usage



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

Warnings

Liver warningThis 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 alertacetaminophen 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 warningIn 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.

Dosage & Administration

Do not take more than directed (see overdose warning)adults•

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
under 18 years of age•

ask a doctor

Storage And Handling



store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).



see end panel for batch number and expiration date



TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredient

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Otc - Questions

Call 1-800-406-7984

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

* Please review the disclaimer below.

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