Drugplain

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 325 mg/1

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate · CAPSULE, LIQUID FILLED · Softgel Healthcare Private Limited

No Recall HistoryCurrently in Shortage
Plain English

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate at 325 mg/1, taken oral. Manufactured by Softgel Healthcare Private Limited.

Key Facts

Brand Name
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
NDC Code (Product)
35916-0154
Manufacturer
Softgel Healthcare Private Limited
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
09/27/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

adverse drug reaction2 reports
dizziness2 reports
abdominal pain upper1 reports
adverse event1 reports
cold sweat1 reports
death1 reports
decreased appetite1 reports
drug screen positive1 reports
dyspnoea1 reports
expired product administered1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Dosage & Administration

Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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.

Frequently Asked Questions

What is Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate used for?

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate contains Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate a controlled substance?

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate?

The generic name for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate is Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate. There are 6 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.

What is the NDC code for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 325 mg/1?

The NDC (National Drug Code) for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 325 mg/1 is 35916-0154, listed by Softgel Healthcare Private Limited.

Product NDC

35916-0154

Package NDC

35916-0154-1

Other Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate Dosages

Other Acetaminophen, Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)