NDC 73282-0011 Childrens Pain And Fever

Acetaminophen 160mg/5ml

NDC Product Code 73282-0011

NDC CODE: 73282-0011

Proprietary Name: Childrens Pain And Fever 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 160mg/5ml 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.

Product Characteristics

Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 73282 - Calmco Llc

NDC 73282-0011-1

Package Description: 20 VIAL in 1 CARTON > 5 mL in 1 VIAL

NDC Product Information

Childrens Pain And Fever with NDC 73282-0011 is a a human over the counter drug product labeled by Calmco Llc. The generic name of Childrens Pain And Fever is acetaminophen 160mg/5ml. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307675.

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.

Childrens Pain And Fever 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MALTITOL (UNII: D65DG142WK)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Calmco Llc
Labeler Code: 73282
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: 08-06-2021 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.

Childrens Pain And Fever Product Label Images

Childrens Pain And Fever 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 5Ml)

Acetaminophen, 160mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

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 maximum daily amount for this product • with other drugs containing acetaminophen.
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
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 containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than 10 days for pain unless directed by a doctor• for more than 3 days for fever unless directed by a doctor

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 warfarin

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.

Overdosage

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 (1-800-222-1222)

Directions

• do not give more than directed (see overdose warning)• use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age• give the recommended number of vials below.• empty each Single-Use Vial required of all liquid when dosing• if needed, repeat dose every 4 hours while symptoms last• do not give more than 5 times in 24 hours• do not give for more than 5 days unless directed by a doctor• this product does not contain directions or complete warnings for adult use.• How to Open & Use:1. Flick the tip before opening so liquid descends.

2. Twist the tip until open and discard immediately.

3. Place open end into child’s mouth and Squeeze to dispense all liquid and discard.
Dosing ChartWeight (lbs)Age (Years)Dose (mL)under 24 lbsunder 2 yearsTalk to a doctor24 -35 lbs2 - 3 years1 Single-Use Vial (5 mL) every 4 hours while symptoms last. Do not exceed 5 Single-Use Vials in 24 hours

Other Information

  • Each Single-Use vial contains 8mg of sodiumstore at 20-25ºC (68-77ºF)tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Inactive Ingredients

Citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

* Please review the disclaimer below.