NDC 58657-525 M-pap

Acetaminophen

NDC Product Code 58657-525

NDC Product Information

M-pap with NDC 58657-525 is a a human over the counter drug product labeled by Method Pharmaceuticals, Llc. The generic name of M-pap is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Method Pharmaceuticals, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

M-pap 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/5mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)

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: Method Pharmaceuticals, Llc
Labeler Code: 58657
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: 08-01-2019 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.

M-pap 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 5 mL teaspoonful)Acetaminophen, USP 160 mg ....................

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:Headachemuscular achesbackachearthritisthe common coldtoothachemenstrual crampsreduces fever

Warnings

  • Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Ask A Doctor Before Use

If you have health issues especially liver disease.

Ask A Doctor Or Pharmacist Before Use

If you are taking other drugs, including the blood thinner warfarin.

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.for more than 10 days for pain unless directed by a doctorfor more than 3 days for fever unless directed by a doctorif you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop Use And Ask A Doctor If

  • New symptoms occur such as rash, hives, itching or hoarsenessredness or swelling is presentpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 dayssymptoms do not improveThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • Do not exceed recommended dosage.Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage. adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed8 teaspoonfuls (40 mL) in 24 hours children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other Information

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive Ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Questions?

1-877-250-3427 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088.Serious side effects associated with use of this product may be reported to this number.See New Warnings InformationTamper evident by foil seal under cap.Do not use if foil seal is broken or missing.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.Distributed by:Method PharmaceuticalsFort Worth, Texas 76118Rev. 06/19

* Please review the disclaimer below.

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