Drugplain

Dr. Simi Children s Cough 5 mg/5mL

Dextromethorphan HBr, Guaifenesin · SYRUP · Farmacias De Similares TX LLC

No Recall History
Plain English

Dr. Simi Children s Cough is a syrup containing dextromethorphan hbr, guaifenesin at 5 mg/5mL, taken oral. Manufactured by Farmacias De Similares TX LLC.

Key Facts

Brand Name
Dr. Simi Children s Cough
Generic Name
Dextromethorphan HBr, Guaifenesin
NDC Code (Product)
85786-604
Manufacturer
Farmacias De Similares TX LLC
Strength
5 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
05/08/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dehydration1 reports
drug ineffective1 reports
dry skin1 reports
feeling hot1 reports
hyperhidrosis1 reports
limb discomfort1 reports
speech disorder1 reports
tremor1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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

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 ■ 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.

Frequently Asked Questions

What is Dr. Simi Children s Cough used for?

Dr. Simi Children s Cough contains Dextromethorphan HBr, Guaifenesin. It is a syrup taken oral. Consult your doctor for specific uses.

Is Dr. Simi Children s Cough a controlled substance?

Dr. Simi Children s Cough is not classified as a controlled substance by the DEA.

What is the generic name for Dr. Simi Children s Cough?

The generic name for Dr. Simi Children s Cough is Dextromethorphan HBr, Guaifenesin. There are 12 other brand versions of Dextromethorphan HBr, Guaifenesin.

What is the NDC code for Dr. Simi Children s Cough 5 mg/5mL?

The NDC (National Drug Code) for Dr. Simi Children s Cough 5 mg/5mL is 85786-604, listed by Farmacias De Similares TX LLC.