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Drug Facts
Dist. By: RB Health (US)
Parsippany, NJ 07054-0224
Made in India
Mucinex Instasoothe Lozenge
FDA Label NDC 72854-262
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Instasoothe (NDC 72854-262). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each lozenge), purpose, uses, sore throat warning, do not use, otc - when using, stop use and ask a doctor or dentist if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 older | take 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 age | take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 2 hours as needed |
| children under 6 years of age | do 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)
* Please review the disclaimer below.
