Dr. Simi Children s Cough

Dr. Simi Children s Cough is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN. It is labelled by Farmacias De Similares TX LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85786-604, application M012, label effective 20260508. It is one of 33 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DEXTROMETHORPHAN HBR, GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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 . 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.

FDA lists 33 drug label records with DEXTROMETHORPHAN HBR, GUAIFENESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Dr. Simi Children s Cough used for?
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.

Who makes Dr. Simi Children s Cough?
Farmacias De Similares TX LLC is the labeler of record for Dr. Simi Children s Cough. 33 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Dr. Simi Children s Cough come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Dr. Simi Children s Cough prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROMETHORPHAN HBR, GUAIFENESIN?
Yes. 33 FDA drug label records list DEXTROMETHORPHAN HBR, GUAIFENESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Dr. Simi Children s Cough been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.