Vicks Sinex Severe Spray
FDA Label NDC 64336-170

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufacturing Gmbh for the product Vicks Sinex Severe (NDC 64336-170). 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 other, active ingredient, purpose, uses, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

MADE IN GERMANY
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure

Otc - Ask Doctor

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland

Otc - When Using

When using this product

  • do not exceed recommended dosage
  • do not use this product 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 increased 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health 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

Questions?

1-800-873-8276

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