Drugplain

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 325 mg/1

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl · CAPSULE, LIQUID FILLED · OPMX LLC

No Recall HistoryCurrently in Shortage
Plain English

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is a prescription capsule, liquid filled containing acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by OPMX LLC.

Key Facts

Brand Name
Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Generic Name
Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
NDC Code (Product)
69729-782
Manufacturer
OPMX LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha1-Agonists [MoA]; Decreased Respiratory Secretion Viscosity [PE]
Marketing Start
02/18/2019

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Temporarily relieves common cold/flu symptoms: Nasal congestion Sinus congestion & pressure Cough due to minor throat & bronchial irritation Minor aches & pain Headache Fever Sore throat Reduces swelling of nasal passages Temporarily restore freer breathing through the nose Promotes nasal and/or sinus drainage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage & Administration

Take only as directed (See overdose warning) Do not exceed 4 doses per 24-hours Adults and children 12 years and over: take 2 softgels with water every 4 hours Children 4 to under 12 years: ask a doctor When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains 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 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 you have: Liver disease High

Frequently Asked Questions

What is Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl used for?

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl contains Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl a controlled substance?

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl?

The generic name for Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl. There are 1 other brand versions of Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl.

What is the NDC code for Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 325 mg/1?

The NDC (National Drug Code) for Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 325 mg/1 is 69729-782, listed by OPMX LLC.

Product NDC

69729-782

Package NDC

69729-782-10

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

Data from openFDA · Public domain (CC0 1.0)