FDA Label for Childrens Mucinex Multi-symptom Cold
View Indications, Usage & Precautions
Childrens Mucinex Multi-symptom Cold 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: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
Otc - Purpose
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Otc - Do Not Use
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Otc - When Using
When using this product do not use more than directed
Stop Use And Ask A Doctor If
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
| Age | Dose |
|---|---|
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 3 mg
- tamper evident: do not use if neckband on bottle cap is broken or missing
- store between 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
may contain this ingredient
, xanthan gumQuestions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - 201 Ml Bottle Carton
VALUE SIZE!
NDC 63824-282-67
Children's
Mucinex®
Multi-Symptom
Cold
Cough Suppressant
Expectorant
Nasal Decongestant
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
✓ Stuffy Nose✓ Cough✓ Chest Congestion✓ Breaks up Mucus
Age 4+
Very Berry
Flavor Liquid
6.8 FL OZ
(201 mL)
* Please review the disclaimer below.