MUCINEX INSTA SOOTHE SORE THROAT WINTER FRESH- benzocaine and menthol, unspecified form spray

Mucinex Insta soothe by

Drug Labeling and Warnings

Mucinex Insta soothe by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzocaine 5%

Menthol 2%

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 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

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.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2023 RB Health
Made in Canada
www.mucinex.com

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

INGREDIENTS AND APPEARANCE

MUCINEX INSTA SOOTHE  SORE THROAT WINTER FRESH
benzocaine and menthol, unspecified form spray

Product 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)