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| Product NDC Code | 21130-728 | ||||
|---|---|---|---|---|---|
| Drug Name | Better living |
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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 | M012 | ||||
| Labeler Name | BETTER LIVING BRANDS 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 Phenylephrine hydrochloride 1%
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 of age & over: 2 or 3 sprays in each nostril not more often than every 4 hours ▪ children under 12 years of age: ask a doctor ▪ Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate
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 for the temporary relief of nasal congestion due to: ▪ common cold ▪ hay fever ▪ 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.Better Living Phenylephrine hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL ANHYDROUS CITRIC ACID WATER SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM (Clear to slightly yellow)
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 the active ingredient in 4-Way Fast Acting Nasal Spray * NDC 21130-728-30 Signature Care ™ Quality Guaranteed Nasal Spray Nasal Decongestant Phenylephrine Hydrochloride Fast acting relief of: • Nasal congestion • Sinus congestion • Sinus pressure • Swollen nasal membranes 1 FL OZ (30mL) DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING Distributed By IMPORTANT: Keep this carton for future reference on full labeling. *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of 4-Way ® Fast acting Nasal Spray. Signature Care Nasal Spray
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. If swallowed, get medical help or contact a Poison Control Center right away at 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? 1-866-467-2748
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.
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 such as burning, stinging, sneezing or an increase in nasal discharge may occur ▪ the 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
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 you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland 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 such as burning, stinging, sneezing or an increase in nasal discharge may occur ▪ the use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 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