Label: PREFERRED PLUS 12 HOUR NASAL EXTRA MOISTURIZING- oxymetazoline hydrochloride spray
- NDC Code(s): 61715-047-01, 61715-047-02
- Packager: Kinray
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Oxymetazoline Hydrochloride, 0.05%Close
- Temporarily relieves nasal decongestion due to: common cold, hay fever, sinusitis, upper respiratory allergies
- Shrinks swollen nasal membranes so you can breathe more freely
- As a doctor before use if you have
- Heart disease
- High blood pressure
- Thyroid disease
- 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
Stop use and ask a doctor if symptoms persists.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.Close
- 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
- To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying. Wipe nozzle clean after use
- Other information
- Store between 20° - 25° C (68° - 77° F)
- Retain carton for future reference on full labeling.
- Inactive ingredients
Benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, waterClose
- INGREDIENTS AND APPEARANCE
PREFERRED PLUS 12 HOUR NASAL EXTRA MOISTURIZING
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-047 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 50.0 mg in 100.0 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-047-02 1 in 1 CARTON 1 NDC:61715-047-01 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/31/2008 Labeler - Kinray (012574513) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Kinray 012574513 label(61715-047) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 pack(61715-047) Establishment Name Address ID/FEI Business Operations Samson Pharmaceuticals 088169581 manufacture(61715-047)