NDC 66689-054 Acetaminophen


NDC Product Code 66689-054

NDC Product Information

Acetaminophen with NDC 66689-054 is a a human over the counter drug product labeled by Vistapharm, Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is solution and is administered via oral form.

Labeler Name: Vistapharm, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • 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: Vistapharm, Inc.
Labeler Code: 66689
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: 11-22-2019 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.

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 (In Each 5 Ml = 1 Teaspoonful)

Acetaminophen...........................160 mg


Pain Reliever/Fever Reducer


  • Temporarily:reduces feverrelieves minor aches and pains due to:the common coldimmunizationsflusore throatheadachetoothache

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 maximum daily amountwith other drugs containing acetaminophen

Allergy 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.

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

Ask A Doctor Before Use If Your Child Has

  • Liver disease

Ask A Doctor Or Pharmacist Before Use If

  • Your child is taking the blood thinning drug warfarinWhen using this product do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • Symptoms do not improvenew symptoms occurredness or swelling is presentpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.

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 even if you do not notice any signs or symptoms.


  • This product does not contain directions or complete warnings for adult use.do not give more than directed (see OVERDOSE WARNING).mL = milliliter; tsp = teaspoonfind right dose on chart below. If possible, use weight to dose; otherwise, use age.repeat dose every 4 hours while symptoms last.do not give more than 5 times in 24 hours.          Weight (1lbs.)                          Age (yrs.)                       Dose (tsp or mL)*         under 24under 2ask a doctor24-352-3 years1 tsp or 5 mL36-474-5 years1 1/2 tsp or 7.5 mL48-596-8 years2 tsp or 10 mL60-71 9-10 years2 1/2 tsp or 12.5 mL72-9511 years3 tsp or 15 mL* or as directed by a doctor

Other Information

  • Store at controlled room temperature 20° - 25°C (68° to 77°F); excursions are permitted to 15° - 30°C (59° to 86°F). [See USP Controlled Room Temperature]Protect from Freezing.Protect from Light.Each teaspoon (5 mL) contains: sodium 7 mg

Inactive Ingredients

Citric acid, FD&C Red #40, flavor, glycerin, polyethylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

How Supplied

Acetaminophen Oral Solution USP, 160 mg per 5 mL is a red solution supplied as follows:NDC 66689-054-01: 5 mL unit-dose cupNDC 66689-054-99: Case contains 100 unit-dose cups of 5 mL (NDC 66689-054-01), packaged in 10 trays of 10 unit-dose cups each.NDC 66689-055-01: 10.15 mL unit-dose cupNDC 66689-055-99: Case contains 100 unit-dose cups of 10.15 mL (NDC 66689-055-01), packaged in 10 trays of 10 unit-dose cups each.NDC 66689-056-01: 20.3 mL unit-dose cupNDC 66689-056-99: Case contains 100 unit-dose cups of 20.3 mL (NDC 66689-056-01), packaged in 10 trays of 10 unit-dose cups each.

Distributed By:

VistaPharm, Inc.Largo, FL 33771, USAVP2158R107/17

* Please review the disclaimer below.