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| Product NDC Code | 70000-0132 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength sinus relief 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 | NASAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1087043 | ||||
| Application Number | part341 | ||||
| Labeler Name | CARDINAL HEALTH | ||||
| 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 ingredients Phenylephrine Hydrochloride 1.0 %
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 ▪ Use only as directed ▪ to spray, squeeze bottle quickly and firmly ▪ adults and children 12 years older: 2 or 3 sprays in each nostril not more often than every 4 hours. ▪ children under 12 years : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate Questions 1-866-467-2748
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 ▪ due to hay fever or other upper respiratory allergies (allergic rhinitis) ▪ temporarily relieves stuffy nose. ▪ 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.Extra Strength Sinus Relief Nasal Decongestant Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID BENZALKONIUM CHLORIDE BENZYL ALCOHOL WATER SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM
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 LEADER NDC 70000-0132-1 COMPARE TO NEO-SYNEPHRINE ® EXTRA STRENGTH active ingredient Extra Strength Sinus Relief Phenylephrine hydrochloride 1.0 % Nasal Decongestant Fast Relief Of: Sinus Congestion & Pressure Colds, Allergies 1 FL OZ (30 mL) * This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine ® Extra Strength. IMPORTANT: Keep this carton for future reference on full labeling. Do not use if printed seal over cap is torn or missing ©2017 Cardinal Health, All Rights Reserved , CARDINAL HEALTH ,the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to care™ since 1979 * This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine ® Extra Strength. LEADER Extra Strength Sinus Relief 1 FL OZ
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 ▪ difficulty in urination due to enlargement of the 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 have ever had an allergic reaction to this product or any of its ingredients
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. If swallowed, 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 1-866-467-2748
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 symptoms persist for more than 3 days.
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 dosage ▪ do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen ▪ temporary discomfort may occur such as burning, stinging, sneezing and increase in nasal discharge ▪ use of this container by more than one person may spread infection
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ▪ store at room temperature ▪ Protect from light.
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 have ever had an allergic reaction to this product or any of its ingredients
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