Label: MUCINEX INSTA SOOTHE SORE THROAT WINTER FRESH- benzocaine and menthol, unspecified form spray
- NDC Code(s): 72854-266-04
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
■ pale, gray, or blue colored skin (cyanosis)
■ headache■ rapid heart rate
■ shortness of breath
■ dizziness or lightheadedness
■ fatigue or lack of energyAllergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Do not use
■ for teething■ in children under 6 years of age
When using this product:
do not exceed recommended dosageStop use and ask a doctor or dentist if
■ sore mouth symptoms do not improve in 7 days
■ irritation, pain, or redness persists or worsens
■ swelling, rash, or fever developsIf pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
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Directions
Adults and children 6 years of age and older:
- apply to affected area (one spray); gargle, swish around in the mouth, or allow to remain in place at least 1 minute then spit out. Use up to 4 times daily or as directed by a doctor or dentist. Children 6 to under 12 years of age SUPERVISE USE
Children under 6 years of age:
- do not use
- Other Infomation
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
MUCINEX INSTA SOOTHE SORE THROAT WINTER FRESH
benzocaine and menthol, unspecified form sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-266 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) HYDROCHLORIC ACID (UNII: QTT17582CB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color yellow (clear to yellow) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-266-04 115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/01/2023 Labeler - RB Health (US) LLC (081049410)
