NDC 73282-0113 Drkids Children Multi Symptom Cold And Flu

Acetaminophen 320mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg

NDC Product Code 73282-0113

NDC CODE: 73282-0113

Proprietary Name: Drkids Children Multi Symptom 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 320mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg 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.

Product Characteristics

Flavor(s):
BERRY (C73365 - MIXED BERRY FLAVOR)

NDC Code Structure

  • 73282 - Calmco
    • 73282-0113 - Drkids Children Multi Symptom Cold And Flu

NDC 73282-0113-6

Package Description: 16 VIAL in 1 CARTON > 10 mL in 1 VIAL

NDC Product Information

Drkids Children Multi Symptom Cold And Flu with NDC 73282-0113 is a a human over the counter drug product labeled by Calmco. The generic name of Drkids Children Multi Symptom Cold And Flu is acetaminophen 320mg, chlorpheniramine maleate 2mg, dextromethorphan hbr 10mg, phenylephrine hcl 5mg. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1357553.

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.

Drkids Children Multi Symptom 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.


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.

  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTITOL (UNII: D65DG142WK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: Calmco
Labeler Code: 73282
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: 01-03-2022 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Drkids Children Multi Symptom Cold And Flu Product Label Images

Drkids Children Multi Symptom 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 Ingredient (In Each 10Ml)

Acetaminophen, 320mg Chlorpheniramine Maleate, 2mgDextromethorphan HBr, 10mg tPhenylephrine HCl, 5mg

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 for this product■ 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■ 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 is allergic to any of the ingredients in this product

Ask A Doctor Befre Use If Your Child Has

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

Ask A Cotor 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 the drowsiness effect

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 fever, rash, or persistent headache. These could be signs of a serious condition.

Overdose Section

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms

Directions


this product does not contain directions or complete warning for adult use■
do not give more than directed (see overdose warning)■ find right dosage on chart below■ empty each Single-Use Vial of all liquid when dosing, following the instructions under "Easy to use" on the side panel■ repeat dose every 4 hours while symptoms last■ do not give more than 5 times in 24 hours■ children under the age of 6, do not useDosing ChartAge (Years)Dose (mL)6 - 11 years1 Single use vial (10mL) every 4 hours. Do not give more than 5 times in 24 hours

Inactive Ingredients

Citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.

Other Information

■ each Single -Use vial contains 11mg of sodium■ store at 20-25°C (68-77°F)■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.

* Please review the disclaimer below.