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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. ACTIVE INGREDIENT (IN EACH LOZENGE)
    3. PURPOSE
    4. USES
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR OR DENTIST IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 20 DROP POUCH BAG

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 India


Active Ingredient (In Each Lozenge)



Hexylresorcinol 2.0 mg


Purpose



Oral pain reliever


Uses



temporarily relieves occasional minor irritation and pain associated with

  • sore throat
  • sore mouth
  • canker sores

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



  • in children under 6 years of age

Otc - When Using



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



  • dose as follows or as directed by a doctor or dentist
    • adults and children 12 years of age and oldertake 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed
    children 6 to under 12 years of agetake 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 2 hours as needed
    children under 6 years of agedo not use

Other Information



  • store at 20-25°C (68-77°F)
  • protect contents from humidity

Inactive Ingredients



corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, sucrose, water


Questions?



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

You may also report side effects to this phone number.


Principal Display Panel - 20 Drop Pouch Bag



CLINICALLY PROVEN
to numb pain FAST*

NDC 72854-262-20

Mucinex®

INSTASOOTHE™

SORE THROAT
+ PAIN RELIEF

Hexylresorcinol 2.0 mg | Oral Pain Reliever

3 IN 1 FORMULA

✓ Relieves Sore Throat Irritation

✓ Maximum Strength Pain Relief*

✓ Fast Acting

*based on amount of
hexylresorcinol per adult dose

See back
panel for
actual size

ELDERBERRY &
WILD CHERRY FLAVOR

20 CT MEDICATED DROPS

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag - mucinex 01

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag - mucinex 01


* Please review the disclaimer below.