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Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in India
Mucinex Instasoothe Lozenge
FDA Label NDC 72854-261
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 72854-261). 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 2.4 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
- adults and children 6 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or directed by a doctor or dentist.
- 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, D&C yellow no. 10, FD&C yellow no. 6, flavor, honey, 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 - 2.4 Mg Pouch Bag
NDC 72854-261-20
Mucinex®
INSTASOOTHE™
SORE THROAT
+ SOOTHING COMFORT
Hexylresorcinol 2.4 mg | Oral Pain Reliever
3IN1 FORMULA
✓ Soothes Throat✓ Relieves Sore Throat Pain✓ Fast Acting
MADE
WITH
REAL
HONEY
See back
panel for
actual size
HONEY &
ECHINACEA FLAVOR
20 MEDICATED DROPS
Principal Display Panel (2.4 mg Pouch Bag)
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