NDC 36800-859 Topcare Childrens Night Time Cold And Cough

Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

NDC Product Code 36800-859

NDC Code: 36800-859

Proprietary Name: Topcare Childrens Night Time Cold And Cough 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: Diphenhydramine Hydrochloride, 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.


Code Structure
  • 36800 - Topco Associates Llc
    • 36800-859 - Topcare Childrens Night Time Cold And Cough

NDC 36800-859-26

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

NDC Product Information

Topcare Childrens Night Time Cold And Cough with NDC 36800-859 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Childrens Night Time Cold And Cough is diphenhydramine hydrochloride, phenylephrine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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 Night Time Cold And Cough 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 6.25 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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: 04-16-2019 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 Night Time Cold And Cough Product Label Images

Topcare Childrens Night Time Cold And Cough 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)

Diphenhydramine HCl 6.25 mgPhenylephrine HCl 2.5 mg

Purposes

Antihistamine/cough suppressantNasal decongestant

Uses

  • •temporarily relieves: •sneezing •itchy nose or throat •runny nose •itchy, watery eyes due to hay fever •nasal and sinus congestion •cough due to minor throat and bronchial irritation as may occur with a cold

Do Not Use

  • •in a child under 4 years of age •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. •with any other product containing diphenhydramine, even one used on skin •to make a child sleepy

Ask A Doctor Before Use If The Child Has

  • •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •cough that occurs with too much phlegm (mucus) •chronic cough that lasts or as occurs with asthma •a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

Taking sedatives or tranquilizers

When Using This Product

  • •do not exceed recommended dosage •may cause marked drowsiness •sedatives and tranquilizers may increase drowsiness •excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • •nervousness, dizziness or sleeplessness occurs •symptoms do not get better within 7 days or occur with fever •cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. •use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.AgeDosechildren under4 years of agedo not usechildren 4 to under6 years of agedo not use unlessdirected by a doctorchildren 6 to under12 years of age10 mL

Other Information

  • •each 5 mL contains: sodium 3 mg •store at 20-25°C (68-77°F)

Inactive Ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

* Please review the disclaimer below.

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