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. 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
Otc - Purpose
Active ingredients (in each 5 mL) | Purpose |
Dextromethorphan HBr 5 mg | Cough suppressant |
Guaifenesin 100 mg | 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
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.
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: 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
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C red #40, flavors, potassium citrate ,propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 118 Ml Bottle Carton
LEADER™
NDC 70000-0131-1
Children's Mucus and Cough Relief
Dextromethorphan HBr , 5 mg
Guaifenesin , 100 mg
Cherry
Flavor
AGES 4-12 YEARS
Controls Cough
Relieves Chest Congestion
Breaks up Mucus
COMPARE TO CHILDREN’S MUCINEX® COUGH active ingredients
100% Money Back Guarantee
Dosing Cup included
4 FL OZ
(118 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Children’s Mucinex® Cough.
IMPORTANT: Keep this carton for future reference on full labeling. |
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to Care™ since 1979
All Leader Brand Products have a 100% Money Back Guarantee
Return to place of purchase if not satisfied
* Please review the disclaimer below.