Cold and Flu 325 mg/1
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · PUBLIX SUPER MARKETS INC
Cold and Flu is a tablet, coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by PUBLIX SUPER MARKETS INC.
Key Facts
- Brand Name
- Cold and Flu
- Generic Name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- NDC Code (Product)
56062-198- Manufacturer
- PUBLIX SUPER MARKETS INC
- Strength
- 325 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 09/13/2019
Recall History
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Procter & Gamble Co
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 inclide: 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. Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes hig…
Frequently Asked Questions
What is Cold and Flu used for?
Cold and Flu contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Cold and Flu a controlled substance?
Cold and Flu is not classified as a controlled substance by the DEA.
What is the generic name for Cold and Flu?
The generic name for Cold and Flu is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE.
What is the NDC code for Cold and Flu 325 mg/1?
The NDC (National Drug Code) for Cold and Flu 325 mg/1 is 56062-198, listed by PUBLIX SUPER MARKETS INC.
Other Acetaminophen, Brands
See all →- Mucinex Fast-Max Kickstart Severe Cold and Flu650 mg/20mL72854-138
- DayQuil Severe plus Vicks VapoCool Cold and Flu325 mg/137000-524
- Cold Flu Severe325 mg/137808-663
- Maximum Strength Mucinex Fast-Max Cold and Flu325 mg/163824-518
- Maximum Strength Mucinex Fast-Max Cold and Flu650 mg/20mL63824-527
- Mucinex Fast-Max Cold, Flu and Sore Throat325 mg/163824-591
- Sinus Relief Pressure, Pain and Cough325 mg/163941-399
- Tylenol Cold plus Flu Severe, TRAVEL BASIX325 mg/166715-7856
- head congestion plus flu severe PE325 mg/141250-574
- Cold Flu Severe325 mg/146122-418
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)