Drug Facts
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Dr Kids Solution
FDA Label NDC 73282-2523
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calmco Llc for the product Dr Kids (NDC 73282-2523). 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 ingredient and purpose, otc - purpose, uses, do not use, ask a doctor before use if your child has, stop use and ask a doctor if your child has, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient And Purpose
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Otc - Purpose
| Active ingredient (in each 5 mL vial) | Purpose |
| Dextromethorphan HBr 5mg.............. | Cough supressant |
| Guaifenesin 100mg............ | Expectorant |
Uses
- temporarily relieves cough due to minor bronchial irritation associated with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Do Not Use
- if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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 Your Child Has
- a persistent or chronic cough such as occurs with asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Stop Use And Ask A Doctor If Your Child Has
- a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
Keep Out Of Reach Of Children.
In case of accidental 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 exceed 6 doses in a 24-hour period
- follow the “Easy to Use” instructions on the pouch
- use the dose that corresponds to your child’s age
- discard unused portion
Age (Years) | Dose |
| Under 4 | consult a doctor |
| 4 to under 6 | 1 vial every 4 hours |
| 6 to under 12 | 1-2 vials every 4 hours |
| 12 and older | 2-4 vials every 4 hours |
Other Information
- each 5 mL vial contains: sodium 7 mg
- store between 68-77°F (20-25°C)
- do not use if pouch or vial is punctured, torn or open
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water
Questions Or Comments?
+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com
Distributed by: CalmCo LLC, Sarasota, FL 34240
Made in Dominican Republic
* Please review the disclaimer below.
