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Drug Facts
Dist. By: RB Health (US)
Parsippany, NJ 07054-0224
Mucinex Instasoothe Lozenge
FDA Label NDC 72854-268
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 72854-268). 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, warnings, sore throat warning, do not use, otc - when using, 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 mg
Menthol 6.1 mg
Purpose
Hexylresorcinol 2 mg - Oral pain reliever
Menthol 6.1 mg - Cough suppressant
Uses
temporarily relieves:
■ occasional minor irritation and pain due to a sore mouth or sore throat
■ pain associated with canker sores
■ cough due to minor throat and bronchial irritation as may occur with the
common cold
Warnings
Warnings
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
Do Not Use
- in children under 6 years of age
Otc - When Using
When using this product do not exceed recommended dosage
Otc - Stop Use
Ask a doctor before use if you have
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ cough accompanied by excessive phlegm (mucus)
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
■ cough lasts more than 7 days, comes back, or occurs with fever, rash,
or persistent headache. These could be signs of a serious condition.
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 as 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
- keep lozenge in outer pack until use. Reseal outer pack after use.
Inactive Ingredients
D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavor, hydrogenated
starch hydrolysate, isomalt, purified water, sucralose
Questions?
1-866-MUCINEX (1-866-682-4639)
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