Otc - Active Ingredient
Active Ingredient (in each Lozenge) | Purpose |
| Dextromethorphan HBr 5.0 mg | Cough suppressant |
Mucinex Instasoothe Lozenge
FDA Label NDC 72854-267
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 72854-267). 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 otc - active ingredient, uses, otc - purpose, warnings, directions, otc - keep out of reach of children, other infomation, inactives, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily:
■ relieves cough due to minor throat and bronchial irritation as may occur with the common
cold or inhaled irritants
■ helps reduce the intensity of coughing
Otc - Purpose
Purpose:
Dextromethorphan HBr 5 mg: Cough suppressant
Warnings
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
Ask a doctor before use if:
■ 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 if:
- cough lasts more than 7 days, comes back, or occurs with fever,
- rash, or persistent headache. These could be signs of a serious condition.
- ask a health professional before use.
If pregnant or breastfeeding:
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.
Other Infomation
- store at 20-25°C (68-77°F)
- protect contents from humidity
- keep lozenge in outer pack until use. Reseal outer pack after use.
Inactives
FD&C blue no. 1, FD&C red no. 40, flavors, hydrogenated starch
hydrolysate, isomalt, propylene glycol, purified water, sucralose
Questions
1-866-MUCINEX (1-866-682-4639)
Other
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in India
2024 RB Health
Patents: www/reckitt.com/patents
www.mucinex.com
Package Label.Principal Display Panel
NDC 72854-267-20
Mucinex®
INSTASOOTHE™ COUGH RELIEF
Dextromethorphan HBr 5.0 mg | Cough Suppressant
3 IN 1 FORMULA
✔ Quiets Cough
✔ Lasts up to 4 hours
✔ Sugar Free
See back
panel for
actual size
20 MEDICATED DROPS
* Please review the disclaimer below.
