1. Home
  2. Labeler Index
  3. Topco Associates Llc
  4. 76162-720
  5. Label Information: Non-drowsy Daytime Cold And Flu Max Softgels Maximum Strength

FDA Label for Non-drowsy Daytime Cold And Flu Max Softgels Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. LIVER WARNING:
    6. ALLERGY ALERT:
    7. SORE THROAT WARNING:
    8. DO NOT USE
    9. ASK A DOCTOR BEFORE USE IF YOU HAVE
    10. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    11. STOP USE AND ASK A DOCTOR IF
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. CARTON

Non-drowsy Daytime Cold And Flu Max Softgels Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Softgel)



Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg


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?



1-888-423-0139


Carton



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.