FDA Label for Mucus Congestion And Cough Relief Childrens
View Indications, Usage & Precautions
Mucus Congestion And Cough Relief Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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
Phenylephrine HCI 2.5 mg
Purposes
Cough suppressant
Expectorant
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
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
- 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
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 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
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- keep dosing cup with product
- 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 4 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Children's Mucinex® Congestion & Cough active ingredients††
children's
Congestion & Cough Relief
DEXTROMETHORPHAN HBr 5 mg /
COUGH SUPPRESSANT
GUAIFENESIN 100 mg /
EXPECTORANT
PHENYLEPHRINE HCI 2.5 mg /
NASAL DECONGESTANT
- Relief from chest congestion, cough & stuffy nose
- Breaks up mucus
AGES 4 - 11 YEARS
BERRY FLAVOR
DOSAGE CUP PROVIDED
FL OZ (mL)
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Congestion & Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Package Label
WALGREENS Children's Congestion & Cough Relief Berry Flavor
* Please review the disclaimer below.