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| Product NDC Code | 63029-403 | ||||
|---|---|---|---|---|---|
| Drug Name | Little remedies decongestant nasal drops |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1549386 | ||||
| Application Number | part341 | ||||
| Labeler Name | Medtech Products 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 Phenylephrine Hydrochloride 0.125%
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 (nasal use only) Children 2 to under 6 years (with adult supervision): 2 to 3 drops in each nostril, not more often than every 4 hours. Use only recommended amount. Children under 2 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, glycerin, polyethylene glycol, potassium phosphate monobasic, purified water, sodium edta, sodium phosphate dibasic
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 nasal congestion due to common cold, hay fever or other upper respiratory allergies helps clear nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Purpose
Information about the drug product’s indications for use.Purpose Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Little Remedies Decongestant Nasal Drops Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZALKONIUM CHLORIDE EDETATE DISODIUM ANHYDROUS GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM PHOSPHATE, UNSPECIFIED FORM WATER SODIUM PHOSPHATE DIBASIC DIHYDRATE Clear
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 Little Remedies ® DECONGESTANT NOSE DROPS Phenylephrine H Cl / Nasal Decongestant 0.5 FL OZ (15 mL) Little Remedies® DECONGESTANT NOSE DROPS Phenylephrine HCl / Nasal Decongestant 0.5 FL OZ (15 mL)
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.LITTLE REMEDIES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid ---------- Little Decongestant Drops Drug Facts
Other information Do not use if solution is brown or contains a precipitate. Protect from light. Store at 20-25ºC (68-77ºF). See bottle or box for lot number and expiration date.
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 the child has heart disease high blood pressure thyroid disease diabetes
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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800- 754-8853 Mon. – Fri. 8 am to 8 pm EST. www.LittleRemedies.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if
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 temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur the use of this dispenser by more than one person may spread infection do not use more than 3 days. Ues only as directed. Frequest or prolonged use may cause nasal congestion to revcur or worsen.
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 the child has heart disease high blood pressure thyroid disease diabetes When using this product temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur the use of this dispenser by more than one person may spread infection do not use more than 3 days. Ues only as directed. Frequest or prolonged use may cause nasal congestion to revcur or worsen. Stop use and ask a doctor if Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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