Drkids Children Multi Symptom Cold And Flu
Acetaminophen 320mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg
Calmco
Human Otc Drug
NDC 73282-0113Drkids Children Multi Symptom Cold And Flu also known as Acetaminophen 320mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg is a human otc drug labeled by 'Calmco'. National Drug Code (NDC) number for Drkids Children Multi Symptom Cold And Flu is 73282-0113. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Drkids Children Multi Symptom Cold And Flu drug includes Acetaminophen - 320 mg/10mL Chlorpheniramine Maleate - 2 mg/10mL Dextromethorphan Hydrobromide - 10 mg/10mL Phenylephrine Hydrochloride - 5 mg/10mL . The currest status of Drkids Children Multi Symptom Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 73282-0113 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Drkids Children Multi Symptom Cold And Flu |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen 320mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Calmco |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 320 mg/10mL
CHLORPHENIRAMINE MALEATE - 2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 15 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Calmco
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 362O9ITL9D
V1Q0O9OJ9Z
9D2RTI9KYH
04JA59TNSJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 73282-0113-6 | 16 VIAL in 1 CARTON (73282-0113-6) / 10 mL in 1 VIAL | 15 Feb, 2023 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose pain reliever / fever reducer antihistamine cough suppressant nasal decongestant
Product Elements:
Drkids children multi symptom cold and flu acetaminophen 320mg, chlorpheniramine maleate 2mg, dextromethorphan hbr 10mg, phenylephrine hcl 5mg acetaminophen acetaminophen glycerin maltitol edetate disodium sorbitol solution phenylephrine hydrochloride phenylephrine sodium metabisulfite water dextromethorphan hydrobromide dextromethorphan chlorpheniramine maleate chlorpheniramine propylene glycol anhydrous citric acid trisodium citrate dihydrate sodium benzoate sucralose mixed berry flavor
Indications and Usage:
Uses â temporarily relieves the following cold/flu symptoms: â minor aches and pains â headache â sore throat â coughâ stuffy nose â sneezing and runny nose â temporarily reduces fever
Warnings:
Warnings liver warning: t his product contains acetaminophen. severe liver damage may occur if your child takes â more than 5 doses in 24 hours, which is the maximum daily amount for this product â with other drugs containing acetaminophen. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â 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 â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â to make a child sleepy â in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or
Read more... 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. â if your child has is allergic to any of the ingredients in this product ask a doctor befre use if your child has â liver disease â high blood pressure â heart disease â diabetes â thyroid disease â glaucoma â a breathing problem such as chronic bronchitis â persistent or chronic cough such as occurs with asthma â cough that occurs with too much phlegm (mucus) ask a cotor or pharmacist before use if your child is â taking the blood thinning drug warfarin â taking sedatives or tranquilizers when using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. keep out of reach of children 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
Do Not Use:
Warnings liver warning: t his product contains acetaminophen. severe liver damage may occur if your child takes â more than 5 doses in 24 hours, which is the maximum daily amount for this product â with other drugs containing acetaminophen. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â 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 â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â to make a child sleepy â 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. â if your child has is allergic to any of the ingredients in this product ask a doctor befre use if your child has â liver disease â high blood pressure â heart disease â diabetes â thyroid disease â glaucoma â a breathing problem such as chronic bronchitis â persistent or chronic cough such as occurs with asthma â cough that occurs with too much phlegm (mucus) ask a cotor or pharmacist before use if your child is â taking the blood thinning drug warfarin â taking sedatives or tranquilizers when using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. keep out of reach of children 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
When Using:
When using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect
Dosage and Administration:
Directions â this product does not contain directions or complete warning for adult use â do not give more than directed (see overdose warning) â find right dosage on chart below â empty each single-use vial of all liquid when dosing, following the instructions under "easy to use" on the side panel â repeat dose every 4 hours while symptoms last â do not give more than 5 times in 24 hours â children under the age of 6, do not use dosing chart age (years) dose (ml) 6 - 11 years 1 single use vial (10ml) every 4 hours. do not give more than 5 times in 24 hours
Stop Use:
Stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition.
Overdosage:
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
Package Label Principal Display Panel:
Package package
Further Questions:
Questions or comments call 941-202-3207 or visit www.drkids.com