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Drug Facts
Dist. by: RB Health (US)
Parsippany,
NJ 07054-0224
Made in Thailand
Mucinex Instasoothe Lozenge
FDA Label NDC 72854-263
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 72854-263). 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, otc - purpose, uses, sore throat warning, do not use, otc - when using, ask a doctor before use if you have, 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
Otc - Purpose
| Active ingredients (in each lozenge) | Purposes |
|---|---|
| Dextromethorphan HBr 5.0 mg | Cough suppressant |
| Hexylresorcinol 2.0 mg | Oral pain reliever |
Uses
temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold
- occasional irritation and pain due to a sore mouth or sore throat
- pain associated with 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
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- in children under 6 years of age
Otc - When Using
When using this product do not exceed recommended dosage
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much 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
- swelling develops
- 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
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 4 hours as needed, not to exceed 12 lozenges in any 24-hour period |
| children 6 to under 12 years of age | take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in any 24-hour period |
| 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, ethyl lactate, FD&C blue no. 1, 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
NDC 72854-263-20
Mucinex®
INSTASOOTHE™
SORE THROAT
+ COUGH RELIEF
Dextromethorphan HBr 5.0 mg | Cough Suppressant
Hexylresorcinol 2.0 mg | Oral Pain Reliever
3 IN 1 FORMULA
✔ Quiets Cough
✔ Cooling Comfort
✔ Fast Acting
See back
panel for
actual size
ALPINE HERBS &
FRESH MINT FLAVOR
20 MEDICATED DROPS
Principal Display Panel (20 Drop Pouch Bag)
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