Label: REXALL SINUS NASAL PUMP MIST- oxymetazoline hydrochloride 0.05% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-778-01 - Packager: Dollar General
- 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 4, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Uses
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WARNINGS
Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
When using this product
Do not exceed recommended dosage.
This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.The use of this container by more than one person may spread infection
Stop use and ask doctor if
Symptoms persist
If pregnant or breast-feeding, ask a health professional before use
- Keep out of reach of the children
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DOSAGE & ADMINISTRATION
Directions. 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: consult a doctor
shake well before each use. Before using for the first time remove the protective cap from the tip and prime mitered pump by depressing pump firmly several times. To remove the cap, squeeze cap at the base on opposite sides on the two smooth impressions with fingers. While squeezing, twist cap counterclockwise to remove. Remove clip and press down to use. Refer to directions on top of each cap. To reapply cap, turn cap on pump clockwise until it locks. To spray, hold bottle with thumb at base and nozzle between first and second flingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REXALL SINUS NASAL PUMP MIST
oxymetazoline hydrochloride 0.05% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-778 Route of Administration TOPICAL 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) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EUCALYPTOL (UNII: RV6J6604TK) Menthol (UNII: L7T10EIP3A) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Phosphate (UNII: SE337SVY37) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-778-01 30 mL in 1 PACKAGE; Type 0: Not a Combination Product 12/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/21/2015 Labeler - Dollar General (068331990) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(55910-778) , label(55910-778)
