Label: FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE- oxymetazoline spray
- NDC Code(s): 55319-827-30
- Packager: FAMILY DOLLAR (Family Wellness)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 25, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Ask a Doctor before use if you have
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When using this product
- Do not use more than directed
- do not use for more than three 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
- if pregnant or breast-feeding
- Keep out of the reach of children
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Directions
- Adults and children 6 to under 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 consult a doctor.
- Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
Wipe nozzle clean after use.
- Other information
- Inactive Ingredients
- Principal Display Panel- Bottle
- Principal Display panel -Carton
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE
oxymetazoline sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-827 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 50 mg in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID ACETATE (UNII: DSO12WL7AU) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-827-30 1 in 1 CARTON 09/30/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/30/2023 Labeler - FAMILY DOLLAR (Family Wellness) (024472631)
