Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 325 mg/1
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride · CAPSULE, LIQUID FILLED · Prodose, Inc.
This over-the-counter medication combines three active ingredients to help relieve cold and flu symptoms: acetaminophen reduces fever and pain, dextromethorphan suppresses cough, and phenylephrine relieves nasal congestion. It comes as an oral liquid-filled capsule.
Key Facts
- Brand Name
- Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
- Generic Name
- Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
- NDC Code (Product)
68210-5053- Manufacturer
- Prodose, Inc.
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- HUMAN OTC DRUG
- Application #
- M012
- Drug Class
- Adrenergic alpha1-Agonists [MoA]; Sigma-1 Agonist [EPC]
- Marketing Start
- 07/29/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 do not exceed 8 Softgels per 24 hrs adults & children 12 years & over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years 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 hrs, 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 Phenylephrine Hydrochloride used for?
This over-the-counter medication combines three active ingredients to help relieve cold and flu symptoms: acetaminophen reduces fever and pain, dextromethorphan suppresses cough, and phenylephrine relieves nasal congestion. It comes as an oral liquid-filled capsule.
Is Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride a controlled substance?
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride?
The generic name for Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride is Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride. There are no other listed brand versions of Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride.
What is the NDC code for Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 325 mg/1?
The NDC (National Drug Code) for Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 325 mg/1 is 68210-5053, listed by Prodose, Inc..
Other Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)