Active Ingredients
Benzocaine 5%
Menthol 2%
Mucinex Insta Soothe Spray
FDA Label NDC 72854-266
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Insta Soothe (NDC 72854-266). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, other infomation, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Pain Reliever
Uses
temporarily relieves occasional minor irritation and pain associated with
■ sore throat
■ sore mouth
■ canker sores
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 12 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.
- supervise use
- do not use
Children 6 to under 12 years of age:
Children under 6 years of age:
Other Infomation
store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, cetylpyridinium chloride, dibasic sodium phosphate, edetate disodium, flavor, hydrochloric acid*, polyethylene glycol, propylene glycol, purified water, sodium hydroxide*, sucralose
*may contain this ingredient
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Other
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2023 RB Health
Made in Canada
www.mucinex.com
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Principle Display Panel
NDC: 72854-266-04
Mucinex® INSTASOOTHE™
Benzocaine 5.0mg oral pain reliever
Menthol 2.0mg oral pain reliever
✔ Numbs Pain Fast
✔ Maximum Cool
Product Label
* Please review the disclaimer below.
