Mucinex® Instasoothe™

Mucinex® Instasoothe™
SPL v3
SPL
SPL Set ID 6140d487-d87c-4954-9247-83492bcc5738
Route
ORAL
Published
Effective Date 2021-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (7 g) Menthol, Unspecified Form (1 g)
Inactive Ingredients
Anhydrous Citric Acid Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Hydrochloric Acid Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Hydroxide Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves occasional minor irritation and pain associated with

  • sore throat
  • sore mouth
  • canker sores
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients Purpose
Benzocaine 7% Oral pain reliever
Menthol 1% Oral pain reliever
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
Do Not Use
  • for teething
  • in children under 6 years of age
Questions?

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

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.

Other Information
  • store at 20-25°C (68-77°F
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.

Inactive Ingredients

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

When Using This Product

do not exceed recommended dosage

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
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
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

  • Numbs Pain Fast
  • Two Powerful

    Pain Relievers

3.8 FL OZ (115 mL)

500 Doses

CHERRY

FLAVOR SPRAY

031121

3184012


Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain associated with

  • sore throat
  • sore mouth
  • canker sores
Section 42229-5 (42229-5)

Drug Facts

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purpose
Benzocaine 7% Oral pain reliever
Menthol 1% Oral pain reliever
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
Do Not Use (Do not use)
  • for teething
  • in children under 6 years of age
Questions?

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

Allergy Alert (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.

Other Information (Other information)
  • store at 20-25°C (68-77°F
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

do not exceed recommended dosage

Methemoglobinemia Warning (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
Stop Use and Ask A Doctor Or Dentist If (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
Principal Display Panel 115 Ml Bottle Label (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

  • Numbs Pain Fast
  • Two Powerful

    Pain Relievers

3.8 FL OZ (115 mL)

500 Doses

CHERRY

FLAVOR SPRAY

031121

3184012


Advanced Ingredient Data


Raw Label Data

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