NDC 36800-809 Topcare Childrens Cold And Flu

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

NDC Product Code 36800-809

NDC Code: 36800-809

Proprietary Name: Topcare Childrens Cold And Flu 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, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 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.

NDC Code Structure

  • 36800 - Topco Associates Llc

NDC 36800-809-26

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

NDC Product Information

Topcare Childrens Cold And Flu with NDC 36800-809 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Childrens Cold And Flu is acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Topco Associates Llc

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.

Topcare Childrens Cold And Flu 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
  • CHLORPHENIRAMINE MALEATE 1 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 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)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCROSE (UNII: C151H8M554)
  • SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)
  • 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: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-13-2019 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.

Topcare Childrens Cold And Flu Product Label Images

Topcare Childrens Cold And Flu 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 Ingredients (In Each 5 Ml)

Acetaminophen 160 mgChlorpheniramine maleate 1 mgDextromethorphan HBr 5 mgPhenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant

Uses

  • •temporarily relieves the following cold/flu symptoms: •minor aches and pains •headache •sore throat •cough •stuffy nose •sneezing and runny nose •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 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. •to make a child sleepy •in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. •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 •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •persistent or chronic cough such as occurs with asthma •cough that occurs with too much phlegm (mucus) •a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If Your Child Is

  • •taking the blood thinning drug warfarin •taking sedatives or tranquilizers

When Using This Product

  • •do not exceed recommended dosage (see overdose warning) •excitability may occur, especially in children •marked drowsiness may occur •sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • •nervousness, dizziness or sleeplessness occur •pain, nasal congestion or cough gets worse or lasts more than 5 days •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back or occurs with rash or headache that lasts. These 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 36under 4 yearsdo not use36-474 to 5 yearsdo not use unless directed by a doctor48-956 to 11 years10 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, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

* Please review the disclaimer below.