FDA Label for Drkids Childrens Multi Symptom Cold Cough And Congestion Dm
View Indications, Usage & Precautions
Drkids Childrens Multi Symptom Cold Cough And Congestion Dm Product Label
The following document was submitted to the FDA by the labeler of this product Calmco. 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, 5mg
Guaifenesin, 100mg
Phenylephrine HCl, 2.5mg
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 If Your 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
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking any other decongestant or stimulant.
When Using This Product
do not exceed recommended dosage (see overdose warning)
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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
■ this product does not contain directions or complete warnings for adult use
■ do not give more than 6 times in 24 hours
■ give the recommended number of vials below following the instructions under “Easy to Use” on the side panel.
■ empty all liquid in each Single-Use Vial when dosing
■ use the chart below to confirm the dose
Dosing chart
Age (years) | Dose (mL) |
under 4 years | Do not use |
4 to 5 years | 1 Single-Use Vial (5mL) every 4 hours. Do not give more than 6 times in 24 hours |
6 to 11 years | 2 Single-Use Vials (10mL) every 4 hours. Do not give more than 6 times in 24 hours |
Other Information
■ each Single -Use vial contains 5mg of sodium
■ store at 20-25°C (68-77°F)
■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.
Inactive Ingredients
citric acid, edetate disodium, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.
Questions Or Comments?
941-202-3270 or visit www.DrKids.com
Package Label
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