FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each 5 mL)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
- •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
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.
Otc - Ask Doctor
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
Otc - Stop Use
Stop use and ask a doctor if 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 at 1-800-222-1222.
- •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
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
- •each 5 mL contains: sodium 3 mg
- •Tamper -evident: do not use if printed inner seal under cap is torn or missing
- •store at room temperature
- •do not refrigerate
- •dosing cup provided
Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Principal Display Panel - 118 Ml Bottle Carton
Compare to the Active ingredient in Children’s Mucinex Cough*
Mucus &Cough Relief
Each Dose of Cherry Flavored
Mucus & Cough Relief:
Relieves Chest Congestion
Breaks up Mucus
See New Dosing information
4 FL OZ
IMPORTANT: Keep this carton for future reference on full labeling.
DOSAGE CUP INCLUDED
Distributed by C.D.M.A., Inc©
43157 W. Nine Mile
Novi, MI 48376-0995
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®
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