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| Product NDC Code | 67091-325 | ||||
|---|---|---|---|---|---|
| Drug Name | Severe congestion nasal anti-drip nasal decongestant |
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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 | WinCo FOODS, 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 Oxymetazoline hydrochloride 0.05%
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 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: ask a doctor Shake well before use . Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor ,edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum. Questions or comments? Call 800-824-1706 Monday-Friday 9 am -4 pm MST
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 ▪ hay fever ▪ upper respiratory allergies ▪ temporarily relieves sinus congestion and pressure ▪ shrinks swollen nasal membranes so you can breathe more freely
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.Severe Congestion Nasal Anti-Drip Nasal Decongestant Oxymetazoline hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL CAMPHOR, (-)- EDETATE DISODIUM EUCALYPTOL GLYCERIN MENTHOL, UNSPECIFIED FORM MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POLYETHYLENE GLYCOL 400 POVIDONE K90 WATER PROPYLENE GLYCOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS XANTHAN GUM
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 NDC 67091-325-30 *Compare to active ingredient in AFRIN ® No-Drip Severe Congestion WinCo ® FOODS SEVERE CONGESTION Nasal Spray Pump Mist Anti-Drip OXYMETAZOLINE HCL NASAL DECONGESTANT Fast, Powerful Relief From Nasal Congestion 12 Hour Relief 1 FL OZ (30 mL) WinCo Foods SEVERE CONGESTION Nasal Spray Anti-Drip uses a special formulation that prevents dripping from your nose and down your throat. How to use: Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use. TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING IMPORTANT: Keep this carton for future reference on full labeling. DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 *This product is not manufactured and distributed by BAYER, distributor of AFRIN ® No Drip Severe Congestion. The Supermarket Low Price Leader ® 100% Satisfaction Guarantee Comments & Questions? 800-824-1706.www.wincofoods.com WinCo FOODS Severe Congestion Nasal Spray Pump Mist Anti - Drip 1 FL OZ (30 mL)
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? Call 800-824-1706 Monday-Friday 9 am -4 pm MST
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
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 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 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