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| Product NDC Code | 82179-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Kosher meds childrens 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 | M013 | ||||
| Labeler Name | Mollec Inc | ||||
| 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 (in each 5 mL teaspoonful) Diphenhydramine HCl 12.5mg
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 if needed, take every 4-6 hours do not take more than 6 doses in 24 hours Children under 4 years of age: do not use Children 4 to under 6 years of age: do not use unless directed by a doctor Children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)
| Children under 4 years of age: | do not use |
| Children 4 to under 6 years of age: | do not use unless directed by a doctor |
| Children 6 to under 12 years of age: | 1 to 2 teaspoonfuls (12.5 mg to 25 mg) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
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 these symptoms due to hay fever or other respiratory allergies: sneezing itching of the nose or throat runny nose itchy watery eyes temporarily relieves these symptoms due to the common cold: sneezing runny nose
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.Kosher Meds Childrens Allergy Relief Diphenhydramine HCL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE D&C RED NO. 33 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE
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.Product label image description image description
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.Other Information Keep carton for full directions for use each teaspoonful contains: sodium 10 mg store at 20° - 25° C (68° - 77° F) dosage cup provided
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? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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 to make a child sleepy Ask a doctor before use if the child has glaucoma 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 marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness Keep out of reach of children. In case of overdose, get medical 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