Drug Facts
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Childrens Multi-symptom Cold Liquid
FDA Label NDC 41226-937
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Childrens Multi-symptom Cold (NDC 41226-937). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if the child has, when using this product do not use more than directed, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Warnings
Warnings
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
- nervousness, dizziness, or sleeplessness occur
- 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 (1-800-222-1222) right away.
Directions
- do not give 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
| Age | Dose |
children 6 to under 12 years of age | 10 mL every 4 hours |
children 4 to under 6 years of age | 5 mL every 4 hours |
children under 4 years of age | do not use |
Other Information
- each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
Call 1-800-632-6900
Package Label.Principal Display Panel
4-oz-label (4 Oz Label)
4-oz-ifc (4 Oz Ifc)
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