NDC 45014-137 Childrens Accudial Pain Reliever/ Fever Reducer

Product Information

What is NDC 45014-137?

The NDC code 45014-137 is assigned by the FDA to the product Childrens Accudial Pain Reliever/ Fever Reducer which is product labeled by Accudial Pharmaceutical, Inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 45014-137-04 118 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code45014-137
Proprietary Name 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.
Childrens Accudial Pain Reliever/ Fever Reducer
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Accudial Pharmaceutical, Inc.
Labeler Code45014
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-25-2012
Listing Expiration Date 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.
12-31-2017
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Childrens Accudial Pain Reliever/ Fever Reducer?


Product Characteristics

Color(s)RED (C48326)
Flavor(s)BUBBLE GUM (C73368)

Product Packages

NDC Code 45014-137-04

Package Description: 118 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Childrens Accudial Pain Reliever/ Fever Reducer Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Childrens Accudial Pain Reliever/ Fever Reducer Inactive Ingredients UNII Codes

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.

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Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

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Childrens Accudial Pain Reliever/ Fever Reducer Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
Palm Beach Gardens, FL 33408


Active Ingredient (In Each 5 Ml = 1 Teaspoon)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • Temporarily reduces fever


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.
  • with other drugs containing acetaminophen.

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.


Otc - Do Not Use



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 in this product.

Otc - Ask Doctor



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

Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.


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 use more than directed.


Otc - Stop Use



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.


Overdose Warning



Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.


Directions



This product does not contain directions or complete warnings for adult use.

  • shake well before using
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
  • when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
    when weight is unknown: use the age chart on the rotating label.
  • use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
  • Age (yr)Dose (mL or tsp)
    tsp. = teaspoon
    mL = milliliter
    under 6 mos.ask a doctor
    6 mos. to under 22.5 mL or ½ tsp.
    2 to under 45 mL or 1 tsp.
    4 to under 67.5 mL or 1½ tsp.
    6 to under 910 mL or 2 tsp.
    9 to under 1112.5 mL or 2½ tsp.
    11 to under 1215 mL or 3 tsp.
    or as directed by a doctor

    Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.


Other Information



  • each teaspoon contains: sodium 2 mg
  • store between 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients



artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions?



877-434-2036


Principal Display Panel - 120 Ml Bottle Carton



Children's
ACCUDIAL®

Acetaminophen
Oral Suspension

Pain Reliever / Fever Reducer

For ages 6 mos. to
under 12 yrs. or 12-95 lbs.

Alcohol Free • Aspirin Free • Ibuprofen Free

Compares to the active
ingredient in Children's
Tylenol® Oral Suspension.

ROTATING
LABEL FOR
WEIGHT-BASED
DOSING

Bubblegum
Flavor

4 FL.OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)

NDC 45014-137-04


* Please review the disclaimer below.