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  5. Label Information: Mucinex Instasoothe Sore Throat Plus Pain Relief

FDA Label for Mucinex Instasoothe Sore Throat Plus Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. METHEMOGLOBINEMIA WARNING
    5. ALLERGY ALERT
    6. SORE THROAT WARNING
    7. DO NOT USE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR OR DENTIST IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL - 115 ML BOTTLE LABEL

Mucinex Instasoothe Sore Throat Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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

Made in Canada


Otc - Purpose



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

Uses



temporarily relieves occasional minor irritation and pain associated with

  • sore throat
  • sore mouth
  • canker sores

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

Otc - Pregnancy Or Breast Feeding



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


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.


Directions



children 12 years of age and olderapply 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.
children 6 to under 12 years of agesupervise use
children under 6 years of agedo not use

Other Information



  • 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


Questions?



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


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

* Please review the disclaimer below.