FDA Label for Mucus Relief Cough Childrens
View Indications, Usage & Precautions
Mucus Relief Cough Childrens Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, 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.
Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Purposes
Cough suppressant
Expectorant
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
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 taking this product.
Ask A Doctor Before Use If The Child Has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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 any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
age | dose |
children 6 to 12 years | 5-10 mL every 4 hours |
children 4 to 5 years | 2.5-5 mL every 4 hours |
children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to active ingredients in Children's Mucinex® Cough*
Children's
Mucus Relief Cough
dextromethorphan HBr 5 mg
Cough Suppressant
guaifenesin 100 mg
Expectorant
relieves:
- cough
- chest congestion
- breaks up mucus
for ages 4 to 11 years
Alcohol free
Dosing Cup Included
cherry flavor
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Package Label
READYinCASE Children's Mucus Relief Cough
* Please review the disclaimer below.