Drugplain

Coldtac Plus Softgels 325 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride · CAPSULE, LIQUID FILLED · OPMX LLC.

No Recall HistoryCurrently in Shortage
Plain English

Coldtac Plus Softgels is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by OPMX LLC..

Key Facts

Brand Name
Coldtac Plus Softgels
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
NDC Code (Product)
69729-120
Manufacturer
OPMX LLC.
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/30/2023

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. Do not exceed 4 doses per 24 hrs. Adults & children 12 yrs & over 2 softgels with water every 4 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 4 doses 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. Symtoms 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, lasts 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 you have Liver disease Heart

Frequently Asked Questions

What is Coldtac Plus Softgels used for?

Coldtac Plus Softgels contains Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Coldtac Plus Softgels a controlled substance?

Coldtac Plus Softgels is not classified as a controlled substance by the DEA.

What is the generic name for Coldtac Plus Softgels?

The generic name for Coldtac Plus Softgels is Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride. There are 12 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride.

What is the NDC code for Coldtac Plus Softgels 325 mg/1?

The NDC (National Drug Code) for Coldtac Plus Softgels 325 mg/1 is 69729-120, listed by OPMX LLC..