FDA Label for Childrens Mucus And Cough Relief
View Indications, Usage & Precautions
Childrens Mucus And Cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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.
Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Purpose
Cough suppressant
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the impulse to cough to help your child get to sleep
- the intensity of coughing
Warning
.
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
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- mL=milliliter
Age | Dose |
children 6 years to under 12 years | 5 mL-10 mL every 4 hours |
children 4 years to under 6 years | 2.5 mL - 5 mL every 4 hours |
children under 4 years | do not use |
Other Information
- each 5 mL contains: potassium 5 mg, sodium 5 mg
- store between 20 to 25°C (68 to 77°F)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum
Questions Comments?
call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est
Principal Display Panel
LEADER
NDC 70000-0630-1
Children's Mucus & Cough Relief
Dextromethorphan HBr, 5mg
Guaifenesin 100 mg
cough Suppressant
Expectorant
Cherry Flavor
Ages 4+ Years
Controls Cough
Relieves Chest Congestion
Thins and Loosen Mucus
COMPARE TO CHILDREN'S MUCINEX® COUGH
active ingredients*
4 FL OZ (118mL)
* Please review the disclaimer below.