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  5. Label Information: Cafizetamol Forte

FDA Label for Cafizetamol Forte

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. LIVER WARNING
    5. CAFFEINE WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF
    8. ASK A DOCTOR OR PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Cafizetamol Forte Product Label

The following document was submitted to the FDA by the labeler of this product Opmx 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 Caplet)



Acetaminophen 500 mg

Caffeine 65 mg


Purposes



Pain reliever

Pain reliever aid


Uses



  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Caffeine Warning



The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.


Do Not Use



  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask A Doctor Before Use If



you have liver disease


Ask A Doctor Or Pharmacist



if you are taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • any new symptoms occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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 exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information



  • store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.


Questions Or Comments?



Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com


Principal Display Panel



NDC 69729-147-40

CAFIZETAMOL FORTE

Superior Pain, Cold & Fever Relief

40 Caplets


* Please review the disclaimer below.