Drug Facts
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Dr. Simi Children S Cough Syrup
FDA Label NDC 85786-604
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr. Simi Children S Cough (NDC 85786-604). 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, stop use and ask a doctor if, 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
Purposes
| Dextromethorphan HBr 5 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
Uses
■ temporarily relieves cough as may occur with the common cold
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
Warnings
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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
■ persistent or chronic cough such as occurs with asthma
■ cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
■ cough persists for more than 1 week, tends to recur, or is accompanied by a 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.
Directions
■ do not take more than 6 doses in any 24-hour period
■ shake well before use
■ measure only with dosing cup provided
■ keep dosing cup with product
■ 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
■ store at room temperature 15-30°C (59-86°F)
■ Do not refrigerate
■ TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.
Inactive Ingredients
citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Questions Or Comments?
855-280-1079
Principal Display Pane
NDC: 85786-604-04
DR. SIMI
Children’s Cough
Dextromethorphan HBr 5 mg
Cough Suppressant
Guaifenesin 100 mg
Expectorant
Ages 4+ Years
■ Controls cough
■ Relieves chest congestion
■ Breaks up mucus
Free of alcohol, parabens & high fructose corn syrup
4 fl oz (118 mL)
Cherry Flavor
Compare to the active ingredients in Children’s Mucinex® Cough*
*This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex® Cough.
Distributed by:
FARMACIAS DE SIMILARES TX LLC.
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
