NDC 72091-004 Acetaminophen

Acetaminophen

NDC Product Code 72091-004

NDC Product Information

Acetaminophen with NDC 72091-004 is a a human over the counter drug product labeled by Samjan Group Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Samjan Group Inc.

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.

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/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)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: Samjan Group Inc.
Labeler Code: 72091
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: 03-17-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Acetaminophen Product Label Images

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

Otc - Active Ingredient

Active ingredient (per 5mL teaspoonful) Acetaminophen 160 mg

Otc - Purpose

Pain Reliever / Fever Reducer

Uses

Temporarily • relieves minor aches • 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 maximumdaily amount • taken with other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rashIf a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

• with any other drug containing acetaminophen (prescription ornonprescription). If you are not sure whether a drug contains acetaminophen,ask a doctor or pharmacist. • if your child is allergic to acetaminophen or any ofthe inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if your child has a liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Otc - When Using

When using this product: Do not exceed recommended dose.

Stop Use And Ask A Doctor If

• pain gets worse or lasts more than 5 days• fever gets worse or lasts more than 3 days • new symptoms occur• redness or swelling is present. These could be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

• do not take more than directedThis product does not contain directions or complete warnings for adult use.• find dose in chart below, if possible, use weight to dose, otherwise use age• dosage may be repeated every 4 hours as needed, or as directed by a doctor• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoonWeight (lb)Under 2424-3636-4748-5960-7172-95age (yr)Under 22-34-56-89-1011Dosage (mL)ask a doctor5 mL7.5 mL10 mL12.5 mL15 mL

Other Information

• each teaspoonful (5 mL) contains: sodium 7.9 mg• store at room temperature 15°- 30°C (59°-86°F)• protect from freezing • protect from light•
TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

Inactive Ingredients:

Artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

* Please review the disclaimer below.