MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF- benzocaine and menthol, unspecified form spray 
RB Health (US) LLC

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MUCINEX® INSTASOOTHE™
SORE THROAT PLUS PAIN RELIEF

Drug Facts

Active ingredientsPurpose
Benzocaine 7%Oral pain reliever
Menthol 1%Oral pain reliever

Uses

temporarily relieves occasional minor irritation and pain associated with

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 energy

Allergy 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 dosage

Stop 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 develops

If 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.

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 agedo not use

Other information

Inactive ingredients

anhydrous citric acid, cetylpyridinium chloride, dibasic sodium phosphate, edetate disodium, flavor, hydrochloric acid, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sucralose

Questions?

(1-866-682-4639)You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in Canada

PRINCIPAL DISPLAY PANEL - 115 mL Bottle Label

NDC 72854-265-04
ALCOHOL-FREE

Mucinex®
INSTASOOTHE™

SORE THROAT
+ PAIN RELIEF

Benzocaine 7% | Oral Pain Reliever
Menthol 1% | Oral Pain Reliever

3.8 FL OZ (115 mL)
500 Doses
CHERRY
FLAVOR SPRAY

031121
3184012

Label

Label

MUCINEX INSTASOOTHE  SORE THROAT PLUS PAIN RELIEF
benzocaine and menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-265
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-265-04115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2021
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2024
Document Id: 102fd852-609e-bb91-e063-6294a90a45d2
Set id: 6140d487-d87c-4954-9247-83492bcc5738
Version: 3
Effective Time: 20240130
 
RB Health (US) LLC