NDC 0904-6645 Childrens Mapap

Acetaminophen

NDC Product Code 0904-6645

NDC Code: 0904-6645

Proprietary Name: Childrens 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: 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):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
44;450
Score: 2
Flavor(s):
BUBBLE GUM (C73368)

NDC Code Structure

  • 0904 - Major Pharmaceuticals

NDC 0904-6645-24

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Childrens Mapap with NDC 0904-6645 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Childrens Mapap is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Childrens 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 160 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.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 02-25-2005 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]

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Childrens Mapap Product Label Images

Childrens 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

Active Ingredient (In Each Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headachesore throatflutoothachethe common coldtemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:more than 5 doses in 24 hours, which is the maximum daily amount
  • With other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If Your Child Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

Taking the blood thinning drug warfarin.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult usedo not give more than directedfind the right dose on chart below. If possible, use weight to dose; otherwise, use age.chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo not give for more than 5 days unless directed by a doctorWeight (lb)Age (yr)Dose (tablets)* Under 24 Under 2Ask a doctor 24-352-3136-474-51 1/248-59 6-8260-719-102 1/272-95113*or as directed by a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENavoid high humiditystore at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • See end flap for expiration date and lot number

Inactive Ingredients

Citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Primary Display Panel

MAJOR®NDC 0904-6645-24Children'sMāpap®ACETAMINOPHENPain reliever / Fever reducerASPIRIN FREE • IBUPROFEN FREEAGES2-1124 Chewable Tablets,160 mg EACHBubble Gum FlavorTAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGDistributed by MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152 USA M-17Rev. 01/18Re-order No. 70084650844    REV0217A4500844-450

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