NDC 58602-765 Childrens Pain Relief

Acetaminophen

NDC Product Code 58602-765

NDC 58602-765-76

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

NDC Product Information

Childrens Pain Relief with NDC 58602-765 is a 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.

Labeler Name: Aurohealth Llc

Dosage Form: Tablet, 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.

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 Relief 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/1

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.

  • 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)

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: Aurohealth Llc
Labeler Code: 58602
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: 09-13-2017 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.

Childrens Pain Relief Product Label Images

Childrens Pain Relief 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 Tablet)

Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:the common coldfluheadachesore throattoothachetemporarily 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 amountwith other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddeningblistersrash.          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 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness 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 agechew before swallowing; this product will soften in mouth for ease of chewingrepeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (tablets)** or as directed by a doctorunder 24under 2 yearsask a doctor24-352-3 years1 tablet36-474-5 years1½ tablets48-596-8 years2 tablets60-719-10 years2½ tablets72-9511 years3 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 LLC2572 Brunswick PikeLawrenceville, NJ 08648

* Please review the disclaimer below.