FDA Label for Mucinex Instasoothe Sore Throat Plus Cough Relief
View Indications, Usage & Precautions
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 20 DROP POUCH BAG
Mucinex Instasoothe Sore Throat Plus Cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. by: RB Health (US)
Parsippany,
NJ 07054-0224
Made in Thailand
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
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