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  5. Label Information: Excedrin Tension Headache

FDA Label for Excedrin Tension Headache

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. ALLERGY ALERT: ACETAMINOPHEN MAY CAUSE SEVERE SKIN REACTIONS. SYMPTOMS MAY INCLUDE:
    5. LIVER WARNING: THIS PRODUCT CONTAINS ACETAMINOPHEN. SEVERE LIVER DAMAGE MAY OCCUR IF YOU TAKE
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    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

Excedrin Tension Headache Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings 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

Allergy Alert: Acetaminophen May Cause Severe Skin Reactions. Symptoms May Include:



  • •skin reddening
  • •blisters
  • •rash

    • If a skin reaction occurs, stop use and seek medical help right away.


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

Do Not Use



  • •if you are allergic to acetaminophen
  • •with any other drug containing acetaminophen (prescription or nonprescription). 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

Ask A Doctor Or Pharmacist Before Use If You Are



  • •taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If



  • •any new symptoms occur
  • •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

    • These could be signs of a serious condition


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

Other Information



  • •store at 20°-25°C (68°-77°F)
  • •close cap tightly after use
  • •read all product information before using. Keep this box for important information.

Inactive Ingredients



benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide


Questions Or Comments?



1-800-452-0051


Principal Display Panel



NDC 0067-8139-02

EXCEDRIN®

TENSION HEADACHE

Acetaminophen and Caffeine

Pain Reliever / Pain Reliever Aid

Aspirin Free

100 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies

Visit us at www.excedrin.com

46177300


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