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| Product NDC Code | 63187-344 | ||||
|---|---|---|---|---|---|
| Drug Name | Nasal decongestant |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1049160 | ||||
| Application Number | part341 | ||||
| Labeler Name | Proficient Rx LP | ||||
| 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 tablet) • Pseudoephedrine HCl 30 mg
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 older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients • calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide
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.Use(s) • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose
Purpose
Information about the drug product’s indications for use.Purpose • Nasal Congestant
Spl product data elements
Usually a list of ingredients in a drug product.Nasal Decongestant Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE TITANIUM DIOXIDE CALCIUM SULFATE, UNSPECIFIED FORM CARNAUBA WAX FD&C RED NO. 40 GELATIN, UNSPECIFIED KAOLIN ANHYDROUS LACTOSE MAGNESIUM SILICATE SHELLAC SILICON DIOXIDE 12-HYDROXYSTEARIC ACID ACER SACCHARUM POLLEN 1004
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 Rugby® compare to Sudafed® Decongestant active ingredient* NDC 63187-344-24 Nasal Decongestant pseudoephedrine HCl 30 mg Temporarily relieves: • nasal congestion due to cold & allergies withoout drowsiness 24 tablets, 30 mg each TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN Rev 04/13 R-29 DISTRIBUTED BY: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150 www.rugbylaboratories.com Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 63187-344-24
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 • store at room temperature 15º-30ºC (59º-86ºF)
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 • diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland
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 • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
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 right away (1-800-222-1222).
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? 1-800-645-2158
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 • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with fever
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 • do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, • ask a health professional before use.
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 • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland When using this product • do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, • ask a health professional before use. Keep out of reach of children. • In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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