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| Product NDC Code | 82643-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Clorrelief kids |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 2610305, 2610310 |
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| Application Number | part341 | ||||
| Labeler Name | FERRER MEDICAL INNOVATIONS LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chlorpheniramine Maleate 0.5% Purpose Antihistamine
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years and over: For each application, spray 4 times every 4 to 6 hours, do not exceed 6 applications in 24 hours. Children 6 to under 12 years of age: Should be supervised in the use of this product. For each application, spray 2 times every 4 to 6 hours. Do not exceed 3 applications in 24 hours. Children 4 to under 6 years of age: Do not use unless directed by a doctor. Children under 4 years of age: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Vera, glycerin, grapefruit seed extract, hyaluronic acid, peppermint flavor, purified water, stevia, xylitol.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.ClorRelief KIDs Chlorpheniramine Maleate XYLITOL WATER GLYCERIN ALOE VERA WHOLE PEPPERMINT GRAPEFRUIT SEED OIL HYALURONIC ACID STEVIA LEAF CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.ClorRelief Box ClorRelief Kids Carton Outline
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children Do not use to make a child sleepy. In case of overdose, getmedical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product you may get drowsy avoid alcoholic drinks, sedatives & tranquilizers, may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask your doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 15-30° C (59-86° F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks, sedatives & tranquilizers, may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breastfeeding, ask your doctor before use. Keep out of reach of children Do not use to make a child sleepy. In case of overdose, getmedical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API