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| Product NDC Code | 21130-956 | ||||
|---|---|---|---|---|---|
| Drug Name | Signature care original |
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| Type | Brand | ||||
| Pharm Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1000990 | ||||
| Application Number | M012 | ||||
| Labeler Name | SAFEWAY, 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 Purpose Oxymetazoline hydrochloride 0.05%............ Nasal decongestant
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.Distributed by: Better Living Brands LLC P.O. Box 99 Pleasanton, CA 94566-0009 Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate
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.Directions adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: consult a doctor shake well before use. Remove safety seal. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
Spl product data elements
Usually a list of ingredients in a drug product.Signature Care Original Oxymetazoline Hydrochloride POVIDONE K30 WATER OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE SODIUM PHOSPHATE DIBASIC DIHYDRATE POLYETHYLENE GLYCOL 1500 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZYL ALCOHOL EDETATE DISODIUM
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.76095
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 (1-800-222-1222) right away
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 use more than directed 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 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 20-25° (68-77°F)
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
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