Label: MUCINEX CHILDRENS STUFFY NOSE- oxymetazoline hydrochloride solution
- NDC Code(s): 63824-961-22
- Packager: RB Health (US) LLC
- 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 January 11, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you or the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
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 - 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
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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 use. To open, hold by the white grips then squeeze and turn cap. Before using for the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use. To close, turn cap until it "clicks".
DO NOT DISCARD CAP
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
MUCINEX CHILDRENS STUFFY NOSE
oxymetazoline hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-961 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) edetate disodium (UNII: 7FLD91C86K) eucalyptol (UNII: RV6J6604TK) glycine (UNII: TE7660XO1C) menthol, unspecified form (UNII: L7T10EIP3A) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) polysorbate 80 (UNII: 6OZP39ZG8H) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium chloride (UNII: 451W47IQ8X) sodium hydroxide (UNII: 55X04QC32I) camphor (synthetic) (UNII: 5TJD82A1ET) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-961-22 1 in 1 CARTON 03/30/2018 1 22 mL in 1 BOTTLE, PUMP; 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 03/30/2018 Labeler - RB Health (US) LLC (081049410)
