Drugplain

Dr. Simi Daytime Cold and Flu 325 mg/1

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg · CAPSULE, LIQUID FILLED · Farmacias De Similares TX LLC

No Recall HistoryCurrently in Shortage
Plain English

Dr. Simi Daytime Cold and Flu is a capsule, liquid filled containing acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hcl 5 mg at 325 mg/1, taken oral. Manufactured by Farmacias De Similares TX LLC.

Key Facts

Brand Name
Dr. Simi Daytime Cold and Flu
Generic Name
Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
NDC Code (Product)
85786-601
Manufacturer
Farmacias De Similares TX LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
03/30/2026

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever

Dosage & Administration

Directions • take only as directed (see Warnings) • do not exceed 4 doses per 24 hrs adults & children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use • When using other daytime or nighttime products, carefully read each label to ensure correct dosing.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if yo

Frequently Asked Questions

What is Dr. Simi Daytime Cold and Flu used for?

Dr. Simi Daytime Cold and Flu contains Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Dr. Simi Daytime Cold and Flu a controlled substance?

Dr. Simi Daytime Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for Dr. Simi Daytime Cold and Flu?

The generic name for Dr. Simi Daytime Cold and Flu is Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg. There are no other listed brand versions of Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg.

What is the NDC code for Dr. Simi Daytime Cold and Flu 325 mg/1?

The NDC (National Drug Code) for Dr. Simi Daytime Cold and Flu 325 mg/1 is 85786-601, listed by Farmacias De Similares TX LLC.

Product NDC

85786-601

Package NDC

85786-601-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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