FDA Label for Childrens Multi Symptom Cold
View Indications, Usage & Precautions
Childrens Multi Symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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 HCl 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 giving 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 persistent headache. 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 right away (1-800-222-1222).
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• 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 3 mg• do not use if printed neckband is broken or missing• store at 20-25°C (68-77°F)• do not refrigerate• dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-800-719-9260
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Compare to Children’s Mucinex® Multi-Symptom Cold active ingredients
Age 4 +
Children’s
Multi-Symptom
Cold
Cough Suppressant (dextromethorphan HBr)
Expectorant (guaifenesin)
Nasal Decongestant (phenylephrine HCl)
Berry Flavor
Relieves:
Stuffy Nose
Cough
Chest Congestion
Breaks Up Mucus
Alcohol Free
4 FL OZ
(118 mL)
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