Label: DISCOUNT DRUG MART SEVERE NASAL- oxymetazoline hydrochloride spray
- NDC Code(s): 53943-726-30
- Packager: DISCOUNT DRUG MART
- 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 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
-
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 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 reach of children.
-
Directions
- ▪
- adults & children 6 to under 12 years of age & older (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 2 to under 6 years: ask a doctor
- ▪
- children 2 years: do not use
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 between first and second fingers. Without titling 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.
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
DISCOUNT drug mart
FOOD FAIR
NDC# 53943-726-30
Compare to the active ingredient in Vicks® Sinex® Severe*
Severe Nasal Spray
OXYMETAZOLINE HCl 0.05%
NASAL DECONGESTANT
12 HOUR
Cold & allergy congestion
Sinus pressure
Ultra-Fine Mist
1 FL OZ (30 mL)
IMPORTANT: Keep the carton for future reference on full labeling
Distributed by:
Discount Drug Mart
211 Commerce Drive
Medina, OH 44256
SATISFACTION GUARANTEED. IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINA, OHIO 44256.
*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex®
-
INGREDIENTS AND APPEARANCE
DISCOUNT DRUG MART SEVERE NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-726 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-726-30 1 in 1 CARTON 05/21/2019 1 30 mL in 1 BOTTLE, SPRAY; 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 05/21/2019 Labeler - DISCOUNT DRUG MART (047741335)