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| Product NDC Code | 73282-2521 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr kids allergy relief |
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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 | SOLUTION | ||||
| Application Number | M012 | ||||
| Labeler Name | CalmCo 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 and Purpose Active ingredient (in each 5 mL vial) Purpose Diphenhydramine HCl 12.5 mg............... Antihistamine
| Diphenhydramine HCl 12.5 mg............... | 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 do not exceed 12 vials in a 24-hour period follow the “Easy to Use” instructions on pouch Age Dose children 6 to 12 years 1 - 2 vials every 4-6 hours children under 6 years consult a doctor
| children 6 to 12 years | 1 - 2 vials every 4-6 hours |
| children under 6 years | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol, sucralose, xylitol, water
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 runny nose sneezing itchy, watery eyes due to hay fever itchy nose or throat other upper respiratory allergies
Purpose
Information about the drug product’s indications for use.Active ingredient (in each 5 mL vial) Purpose Diphenhydramine HCl 12.5 mg............... Antihistamine
Active ingredient (in each 5mL vial) Purpose Diphenhydramine HCl 12.5 mg..................... Antihistamine
| Diphenhydramine HCl 12.5 mg............... | Antihistamine |
| Diphenhydramine HCl 12.5 mg..................... | Antihistamine |
Spl product data elements
Usually a list of ingredients in a drug product.Dr Kids Allergy Relief Diphenhydramine HCl SUCRALOSE ANHYDROUS CITRIC ACID SORBITOL SODIUM BENZOATE GLYCERIN WATER PROPYLENE GLYCOL XYLITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARBOXYMETHYLCELLULOSE
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.Principal Display Panel Dr kids Allergy PDP
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 your child has glaucoma a breathing problem such as chronic bronchitis
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 your child is taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use with any other product containing diphenhydramine, even one used on skin
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 5 mL vial contains: sodium 2 mg store between 68-77°F (20-25°C) do not use if pouch has been torn open or vial is punctured or open
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? (M-F) 9AM-5PM EST or visit www.DrKids.com Distributed by: CalmCo LLC, Sarasota, FL 34240
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 may cause excitability in children may cause marked drowsiness sedatives and tranquilizers may increase the drowsiness effect
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 Do not use with any other product containing diphenhydramine, even one used on skin Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers When using this product may cause excitability in children may cause marked drowsiness sedatives and tranquilizers may increase the drowsiness effect KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Ask a doctor before use if your child has glaucoma a breathing problem such as chronic bronchitis
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