Winco Foods Severe Congestion Nasal Relief
FDA Label NDC 67091-192

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Foods Severe Congestion Nasal Relief (NDC 67091-192). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, pregnancy, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                                              Purpose

Oxymetazoline HCL 0.05%..............................................................................Nasal decongestant

Otc - Purpose

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

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.

Otc - When Using

When using this product

do not use more than directed

  • do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worse
  • 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.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist.

Pregnancy

If pregnant or breast-feeding, ask ahealth professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control center right away.

Indications & Usage

Directions

  • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more 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.  To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise 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 each use and snap cap back onto the bottle.

Storage And Handling

Other information

  • store between 20° and 25°C (68° and 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredient

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, DL-camphor, eucalyptol, l-menthol, monobasic sodium phosphate dihydrate, polysorbate 80, propylene glycol

Dosage & Administration

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

Package Label.Principal Display Panel

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Image Description (24109)

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