NDC 52083-663 Liquid Acetaminophen


NDC Product Information

Liquid Acetaminophen with NDC 52083-663 is a a human over the counter drug product labeled by Kramer Novis. The generic name of Liquid Acetaminophen is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Kramer Novis

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.

Liquid 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.
  • 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: Kramer Novis
Labeler Code: 52083
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: 03-02-2020 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.

Liquid Acetaminophen Product Label Images

Liquid 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 Tsp)

Acetaminophen, 160 mg


Pain reliever/Fever reducer


Temporarily relieves of minor aches and pains due to • headache • backache • muscular aches • minor pain of arthritis • the common cold • toothache • premenestrual and menstrual crampsTemporarily reduces fever.


Liver warning: This product contains acetaminophen. Severe liver damage may occur if:• adults take more than 6 doses in 24 hours, which is the maximum daily amount• child takes more than 5 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen (prescription or nonprescription) • adults has 3 or more alcoholic drinks while using this productAllergy 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 awayDo not use with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE Ask a doctor before use if you have a liver disease.Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults • pain gets worse or lasts more than 5 days in children under 12 years• 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.If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.


Dosage may be repeated every 4 hours, or as directed by doctor. Do not exceed recommended dose.Find dose in chart below. If possible, use weight to dose, otherwise use age. Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 Over 95 Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage teaspoonful (tsp) consult a doctor 1 tsp(5 mL) 1 1/2 tsp(7.5 mL) 2 tsp(10 mL) 2 1/2 tsp(12.5 mL) 3 tsp(15 mL) 4 tsp(20 mL)

Other Information

• Store at controlled room tempearature 15°-30°C (59°-86°F). Do not refrigerate. • Protect from light. Avoid excessive heat or humidity.

Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose

* Please review the disclaimer below.