Label: NO DRIP SEVERE CONGESTION PREMIER VALUE- oxymetazoline hcl nasal solution spray
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-309-03 - Packager: Chain Drug Consortium
- 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 October 14, 2015
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
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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 and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- Adults and children 6 to 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 within any 24-hour period.
- Children under 6 years of age: Ask a doctor.
Shake well before use. Before using for the first time remove the protective cap from the tip and 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 tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after each use.
- Other Information
- Inactive Ingredients
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Additional information listed on other panels
SAFETY SEALED: DO NOT USE IF IMPRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks Sinex.
Distributed By:
Chain Drug Consortium
3301 NW Boca Raton Blvd, Suite 101
Boca Raton, FL 33431
Made in USA
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
- Principal Display
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INGREDIENTS AND APPEARANCE
NO DRIP SEVERE CONGESTION PREMIER VALUE
oxymetazoline hcl nasal solution sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-309 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) MENTHOL (UNII: L7T10EIP3A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-309-03 1 in 1 CARTON 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 11/04/2014 Labeler - Chain Drug Consortium (101668460) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(68016-309)
