Mucinex® Instasoothe™ Sore Throat Winter Fresh

Mucinex® Instasoothe™ Sore Throat Winter Fresh
SPL v3
SPL
SPL Set ID f7a6ed6d-2b71-b9a2-e053-6394a90a04ef
Route
ORAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 g) Menthol, Unspecified Form (2 g)
Inactive Ingredients
Edetate Disodium Polyethylene Glycol, Unspecified Sodium Phosphate, Dibasic, Unspecified Form Water Anhydrous Citric Acid Sucralose Cetylpyridinium Chloride Hydrochloric Acid Propylene Glycol Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-01 Until 2026-07-12

Description

Benzocaine 5% Menthol 2%

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Benzocaine 5% Menthol 2%

Uses

temporarily relieves occasional minor irritation and pain associated with

■ sore throat

■ sore mouth

■ canker sores

Section 42229-5

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

©2023 RB Health

Made in Canada

www.mucinex.com

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Infomation

store at 20-25°C (68-77°F)

Active Ingredients

Benzocaine 5%

Menthol 2%

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

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


Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain associated with

■ sore throat

■ sore mouth

■ canker sores

Section 42229-5 (42229-5)

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

©2023 RB Health

Made in Canada

www.mucinex.com

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Oral Pain Reliever

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
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Infomation

store at 20-25°C (68-77°F)

Active Ingredients

Benzocaine 5%

Menthol 2%

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)