Label: MAX STR.NASAL RELIEF SEVERE CONGESTION- oxymetazoline hydrochloride 0.05% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1232-1 - Packager: Ride Aid
- 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 June 18, 2018
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- INDICATIONS & USAGE
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Warnings
Ask a doctor before use if you have
• heart disease• high blood pressure• thyroid disease
• diabetes• trouble urinating due to enlarged prostate glandWhen using this product
Do not use this product if you have heart disease • high
blood pressure • thyroid disease • diabetes • or difficulty
in urination due to enlargement of the prostate gland
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. • Do not use for more than 3 days. Use only as
directed. • Frequent or prolonged use may cause nasal
congestion to recur or worsen.
Stop use and ask doctor if symptoms persist,
consult a doctor. -
Directions
Before using the first time, remove the protective cap from the tip and prime 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 use. • adults and children 6 to under12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 1 2 hours. Do not exceed 2 doses within any 24-hour period • children under 6 years of age: consult a doctor - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAX STR.NASAL RELIEF SEVERE CONGESTION
oxymetazoline hydrochloride 0.05% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1232 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) Benzyl Alcohol (UNII: LKG8494WBH) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Edetate Disodium (UNII: 7FLD91C86K) Eucalyptol (UNII: RV6J6604TK) Menthol (UNII: L7T10EIP3A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Povidone (UNII: FZ989GH94E) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1232-1 1 in 1 CARTON 05/09/2014 1 15 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 05/09/2014 Labeler - Ride Aid (014578892) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(11822-1232) , label(11822-1232)
