NDC 61919-875 Mapap

Mapap

NDC Product Code 61919-875

NDC Code: 61919-875

Proprietary Name: Mapap 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: Mapap 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: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
GPI;A325
Score: 1

NDC Code Structure

  • 61919 - Directrx
    • 61919-875 - Mapap

NDC 61919-875-71

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Mapap with NDC 61919-875 is a a human over the counter drug product labeled by Directrx. The generic name of Mapap is mapap. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Directrx

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Mapap 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 325 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.

  • POVIDONE K12 (UNII: 333AG72FWJ)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: part343 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-01-2019 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.

Mapap Product Label Images

Mapap 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: MAJOR® PHARMACEUTICALS17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

Otc - Active Ingredient

Active ingredient (in each tablet)Acetaminophen 325 mg

Otc - Purpose

PurposesPain reliever/fever reducer

Indications & Usage

Usesfor the temporary relief of minor aches and pains due to:

headache

muscular aches

backache

minor pain of arthritis

the common cold

toothache

premenstrual and menstrual cramps

temporarily reduces fever

Warnings

WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 4,000 mg in 24 hours

child takes more than 5 doses in 24 hours, which is the maximum daily amount

taken with other drugs containing acetaminophen

adult has 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 usewith 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 the user has liver disease.Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.Stop use and ask a doctor ifpain gets worse or lasts more than 10 days in adults

pain gets worse or lasts more than 5 days in children under 12 years

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.

Dosage & Administration

Directionsdo not take more than directed (see overdose warning)AGE DOSE

Adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last

do not take more than 10 tablets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor
Children 6 years to under 12 yearstake 1 tablet every 4 to 6 hours while symptoms last

do not take more than 5 tablets in 24 hours

do not use for more than 5 days unless directed by a doctor
Children under 6 years ask a doctor

Storage And Handling

Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientsPovidone, pregelatinized starch, sodium starch glycolate, stearic acid

Otc - Questions

Questions or comments?Call (800) 616-2471

Other Safety Information

Do not use if imprinted Safety Seal under cap is broken or missing

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

* Please review the disclaimer below.

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