NDC 49638-112 Tylo Extra (acetaminophen)

Acetaminophen

NDC Product Code 49638-112

NDC Code: 49638-112

Proprietary Name: Tylo Extra (acetaminophen) 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.


Code Structure
  • 49638 - America Medic & Science, Llc
    • 49638-112 - Tylo Extra (acetaminophen)

NDC 49638-112-30

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Tylo Extra (acetaminophen) with NDC 49638-112 is a a human over the counter drug product labeled by America Medic & Science, Llc. The generic name of Tylo Extra (acetaminophen) is acetaminophen. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: America Medic & Science, Llc

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

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.


Tylo Extra (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 1000 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: America Medic & Science, Llc
Labeler Code: 49638
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: 01-17-2019 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.

Tylo Extra (acetaminophen) Product Label Images

Tylo Extra (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

Tylo Extra 1000 Mg

Drug Facts

Active Ingredient

Acetaminophen 1000 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headachebackacheminor pain of arthritistemporarily reduces feverthe common coldtoothachemenstrual crampsmuscular aches

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product.

Do Not Use

  • With any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Overdose Warning

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 1 caplet every 6 to 8 hoursDo not take more than 4 caplets of this product in 24 hours.Children under 12 years:do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • Store between 20-25°C (68-77°F)see end panel for lot number and expiration date

Inactive Ingredients

  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

* Please review the disclaimer below.

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