Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Non-drowsy Daytime Cold And Flu Max Softgels Maximum Strength
FDA Label NDC 76162-720
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Non-drowsy Daytime Cold And Flu Max Softgels Maximum Strength (NDC 76162-720). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each softgel), purposes, uses, warnings, liver warning:, allergy alert:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains
• headache
• cough
• sore throat
• nasal and sinus congestion
• temporarily reduces fever
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 or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash n hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or general allergic 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
• 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 to this product or any of its ingredients
• in children under 12 years of age
Ask A Doctor Before Use If You Have
• liver disease n heart disease n high blood pressure
• thyroid disease n diabetes
• cough with excessive phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
Stop Use And Ask A Doctor If
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• nervousness, dizziness, or sleeplessness occurs
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• do not take more than the recommended dose
• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
• children under 12 years: do not use
Other Information
• store at room temperature. Avoid temperatures above 25°C (77°F).
Inactive Ingredients
FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide
Questions Or Comments?
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TopCare health
NDC 36800-720-24
COMPARE TO ALKA-SELTZER® PLUS®
MAXIMUM STRENGTH DAYTIME COLD & FLU
POWERMAXTM GELS ACTIVE INGREDIENTS*
NON-DROWSY DAYTIME
Cold & Flu Max Softgels
MAXIMUM STRENGTH
PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
NASAL DECONGESTANT - PHENYLEPHRINE HCl
RELIEVES:
• Nasal Congestion
• Cough
• Headache & Body Ache
• Sore Throat
• Sinus Pressure
•Smaller Capsule •Same Strength
24SOFTGELS**
**Liquid-Filled Capsules
minis
* Please review the disclaimer below.
