Drugplain

COLDTAC ULTRA 500 mg/1

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl · TABLET · OPMX LLC

No Recall HistoryCurrently in Shortage
Plain English

COLDTAC ULTRA is a tablet containing acetaminophen, chlorpheniramine maleate, phenylephrine hcl at 500 mg/1, taken oral. Manufactured by OPMX LLC.

Key Facts

Brand Name
COLDTAC ULTRA
Generic Name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
NDC Code (Product)
69729-133
Manufacturer
OPMX LLC
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
01/10/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

hypersensitivity1 reports
urticaria1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Dosage & Administration

Directions: Do not take more than directed - see overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets 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. if you have ever had an allergic reaction

Frequently Asked Questions

What is COLDTAC ULTRA used for?

COLDTAC ULTRA contains Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl. It is a tablet taken oral. Consult your doctor for specific uses.

Is COLDTAC ULTRA a controlled substance?

COLDTAC ULTRA is not classified as a controlled substance by the DEA.

What is the generic name for COLDTAC ULTRA?

The generic name for COLDTAC ULTRA is Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl.

What is the NDC code for COLDTAC ULTRA 500 mg/1?

The NDC (National Drug Code) for COLDTAC ULTRA 500 mg/1 is 69729-133, listed by OPMX LLC.