NDC 70000-0481 Leader Childrens Pain And Fever

Acetaminophen

NDC Product Code 70000-0481

NDC 70000-0481-1

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Leader Childrens Pain And Fever with NDC 70000-0481 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Childrens Pain And Fever is acetaminophen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Leader 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.

  • 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CALCIUM SULFATE (UNII: WAT0DDB505)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)

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: Cardinal Health
Labeler Code: 70000
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: 02-25-2019 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: 12-31-2020 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.

Leader Childrens Pain And Fever Product Label Images

Leader 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 5 Ml)

Acetaminophen 160 mg

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 •with other drugs containing acetaminophenAllergy 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 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 has ever had an allergic reaction to this product or any of its ingredients

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 dose (see overdose warning)

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 presentThese could be signs of a serious condition.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 •do not give more than directed (see overdose warning) •shake well before using •mL = milliliter •find right dose on chart below. If possible, use weight to dose; otherwise, use age. •remove the child protective cap and squeeze your child’s dose into the dosing cup •repeat dose every 4 hours while symptoms last •do not give more than 5 times in 24 hours Weight (lb)Age (yr)Dose (mL)*under 24under 2 yearsask a doctor24-352-3 years5 mL36-474-5 years7.5 mL48-596-8 years10 mL60-719-10 years12.5 mL72-9511 years15 mL *or as directed by a doctorAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • •each 5 mL contains: sodium 3 mg •store at 20-25°C (68-77°F) •do not use if printed neckband is broken or missing

Inactive Ingredients

Anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

* Please review the disclaimer below.

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