NDC 81389-001 Safetynadol

Acetaminophen

NDC Product Code 81389-001

NDC 81389-001-01

Package Description: 200 TABLET, COATED in 1 BOTTLE

NDC Product Information

Safetynadol with NDC 81389-001 is a a human over the counter drug product labeled by Sinew Pharma Inc.. The generic name of Safetynadol is acetaminophen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Sinew Pharma Inc.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Safetynadol 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 500 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 K30 (UNII: U725QWY32X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • MANNITOL (UNII: 3OWL53L36A)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • 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: Sinew Pharma Inc.
Labeler Code: 81389
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: 01-21-2021 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: 12-31-2022 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.

Safetynadol Product Label Images

Safetynadol 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

Activeingredient(Ineachtablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

■Temporarily relieves minor aches and pains due to:


■the common cold ■headache ■backache ■minor pain of arthritis ■muscular aches ■toothache ■premenstrual and menstrual cramps ■Temporarily reduces feverr

Warnings

Liver warning: This products acetaminophen. Severe liver damage may occur if you take


■more than 4,000 mg of acetaminophen in 24 hours


■with other drugs containing acetaminophen


■3 or more alcohol 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 Use

■with any other drug captaining acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.


■if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use

If you have liver disease

Ask A Doctor Or A Pharmacist Before Use

If you are taking blood thinning drug warfarin

Stop Use And Ask A Doctor If

■pain gets worse or last more than 10 days ■new symptoms occur ■fever gets worse or lasts more than 3 days ■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 over dose, 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 2 tablets every 6 hours while symptoms last


■do not take more than 6 tablets in 24 hours, unless directed by a doctor


■do not use for more than 10 days unless directed by a doctor


 Children under 12 years Ask a doctor

Other Information

Store at 20-25 °C (66-77 °F)

Inactive Ingredients

Pregelatinized Starch, polyvinylpyrrolidone K-30, Corn starch, Stearic acid, Sodium Starch Glycolate, Mannitol, Sucralose, Low Substituted Hydroxyproply Cellulose, light anhydrous silicic acid, Magnesium stearate, PEG 6000, Hydroxypropyl methylcellulose 6cps, Titanium dioxide, Sicopharm yellow 10, Sicopharm red 30

* Please review the disclaimer below.