NDC 58602-765 Childrens Pain Relief
Acetaminophen Tablet, Chewable Oral

Product Information

Childrens Pain Relief is a human over the counter drug product labeled by Aurohealth Llc. The generic name of Childrens Pain Relief is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Product Code58602-765
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 Pain Relief
Non-Proprietary Name 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.
Acetaminophen
Product Type 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.
Human Otc Drug
Dosage FormTablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
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.
Aurohealth Llc
Labeler Code58602
FDA Application Number 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.
part343
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.
09-13-2017
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.
12-31-2023
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".
N
NDC Code Structure

What are the uses for Childrens Pain Relief?


Product Characteristics

Color(s)PURPLE (C48327)
ShapeROUND (C48348)
Size(s)16 MM
Imprint(s)J26
Score2
Flavor(s)GRAPE (C73391)

Product Packages

NDC 58602-765-76

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, CHEWABLE in 1 BLISTER PACK

Product Details

What are Childrens Pain Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 160 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

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:

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.
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

* Please review the disclaimer below.

Childrens Pain Relief Labeling and Warnings

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.

Table of Contents



Active Ingredient (In Each Tablet)



Acetaminophen USP 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

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
    • with other drugs containing acetaminophen
    • 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.

        • 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 in 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 warfarin.


When Using This Product



do not exceed recommended dosage.


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.



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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions




  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

  • Weight (lb)
    Age (yr)
    Dose (tablets)*
    * or as directed by a doctor
    under 24
    under 2 years
    ask a doctor
    24-35
    2-3 years
    1 tablet
    36-47
    4-5 years
    1½ tablets
    48-59
    6-8 years
    2 tablets
    60-71
    9-10 years
    2½ tablets
    72-95
    11 years
    3 tablets


Other Information




  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients



citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, FD &C Blue No.1 lake, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


Questions or comments?

Call 1-855-274-4122


* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


Package Label-Principal Display Panel - 160 Mg (24 Chewable Tablets)



AUROHEALTH
NDC 58602-765-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer
 

* Please review the disclaimer below.