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  5. Label Information: Tension Headache Relief

FDA Label for Tension Headache Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. ACTIVE INGREDIENTS (IN EACH CAPLET)
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE
    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. TENSION HEADACHE RELIEFACETAMINOPHEN 500MGCAFFEINE 65MG24 CAPLETSCOMPARE TO EXCEDRIN® TENSION HEADACHE ACTIVE INGREDIENTS DISTRIBUTED BY:HEALTHLIFE OF USA LLCRAHWAYNJ 07065WWW.HEALTHLIFEOFUSA.COM

Tension Headache Relief Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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.

Drug Facts



Tension Headache Relief


Purpose



Pain reliever, Pain reliever aid


Active Ingredients (In Each Caplet)



Acetaminophen   500mg

Caffeine   65mg


Uses



Temporarily relief minor aches and pains due to:

  • Headache
  • Muscular aches

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
  • 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 appear
  • 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 overdosage, get medical help or contact a Poison Control Center (1-800-222-1222) 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 tablets every 6 hours; do not take more than 6 tablets 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 

Inactive Ingredients



  • Colloidal silicon doixide
  • Croscarmellose sodium
  • D&C red # 27
  • FD&C blue # 1
  • FD&C yellow # 6
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Pregelatinized starch
  • Polyvinyl pyrolidone
  • Stearic acid
  • Talc
  • Titanium dioxide

Questions Or Comments?



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