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| Product NDC Code | 68210-4109 | ||||
|---|---|---|---|---|---|
| Drug Name | Nasal decongestant |
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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 | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1049182 | ||||
| Application Number | M012 | ||||
| Labeler Name | Spirit Pharmaceuticals 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 (in each tablet) Phenylephrine HCl 10 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 over ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
| adults and children 12 years and over | ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours |
| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide *contains one or more of these ingredients
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 sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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.Nasal Decongestant Phenylephrine HCl CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM LAKE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 SODIUM STARCH GLYCOLATE TYPE A CORN STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE tablet 272;S08;T234
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 COMPARE TO ACTIVE INGREDIENT IN SUDAFED® PE CONGESTION®† MAXIMUM STRENGTH Nasal Decongestant · Phenylephrine HCl 10 mg - Nasal Decongestant †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion 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.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 you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland
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)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20° to 25°C (68° to 77°F)
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? 1-888-333-9792
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 a 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)
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 exceed recommended dose
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 for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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