NDC 50488-4160 Acetaminophen

Acetaminophen

NDC Product Information

Acetaminophen with NDC 50488-4160 is a a human over the counter drug product labeled by Alexso, Inc. The generic name of Acetaminophen is acetaminophen. The product's dosage form is bar, chewable and is administered via oral form.

Labeler Name: Alexso, Inc

Dosage Form: Bar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.

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 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.

  • HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • MALTITOL (UNII: D65DG142WK)
  • SUCROSE (UNII: C151H8M554)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • NEOTAME (UNII: VJ597D52EX)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • WATER (UNII: 059QF0KO0R)

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: Alexso, Inc
Labeler Code: 50488
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: 11-01-2019 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: 12-31-2021 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.

Acetaminophen 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

Acetaminophen 160mg

Purpose

Pain reliever/fever reducer

Uses

Acetaminophen 160mg Chewable Gel is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if:adult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 10 doses in 24 hourswith other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist. adults has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may includeskin 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 other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product.Take under the supervision of a physician if you have liver disease, taking a blood thinning drug called warfarin, or have a history of high blood pressure or diabetes.

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)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

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.

Directions

  • Do not take more than directed (see overdose warning) Adults and children 12 years and over:take 4 chewable gels every 4 to 6 hours while symptoms last or as directed by a physicianchew each chewable gel thoroughly before swallowingdo not take more than 20 chewable gels in 24 hoursdo not take for more than 10 days unless directed by a physicianChildren 6 to 11 years:take 2 chewable gels every 4 to 6 hours while symptoms last or as directed by a physicianchew each chewable gel thoroughly before swallowingdo not take more than 10 chewable gels in 24 hoursdo not take for more than 5 days unless directed by a physicianChildren under 6 years: ask a physician

Other Information

  • Each chewable gel contains: sodium 7.44 mg.each chewable gel contains: sugar 2g. store in a cool dry place between 20-25°C (68-77°F).Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients:

Hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

How Supplied

Acetaminphen 160mg Chewable Gel is supplied in the following dosage form:Fourteen (14) chewable gels per containerMade in USARx OnlyManufactured for: Alexso, Inc. 2317 Cotner AveLos Angeles, CA 90064NDC: 50488-4160-1 Size: 14 Chewable Gels

* Please review the disclaimer below.