1. Home
  2. Labeler Index
  3. L. Perrigo Company
  4. 0113-1855
  5. Label Information: Good Sense Headache Relief

FDA Label for Good Sense Headache Relief

View Indications, Usage & Precautions

Table of Contents

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

Good Sense Headache Relief Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo Company. 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 Geltab)



Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever

Pain reliever aid


Uses



  • •temporarily relieves minor aches and pains due to:
  • •headache
  • •a cold
  • •arthritis
  • •muscular aches
  • •toothache
  • •premenstrual & menstrual cramps

Warnings



Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • •hives
    • •facial swelling
    • •asthma (wheezing)
    • •shock

      • 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

        • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

        • •are age 60 or older
        • •have had stomach ulcers or bleeding problems
        • •take a blood thinning (anticoagulant) or steroid drug
        • •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
        • •have 3 or more alcoholic drinks every day while using this product
        • •take more or for a longer time than directed

          • 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 heart beat.


Do Not Use



  • •if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • •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
  • •stomach bleeding warning applies to you
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • •you are taking a diuretic
  • •you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are



taking

  • •a prescription drug for diabetes, gout, or arthritis
  • •any other drug, or are under a doctor’s care for any serious condition

Stop Use And Ask A Doctor If



  • •an allergic reaction occurs. Seek medical help right away.
  • •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have stomach pain that does not get better
  • •ringing in the ears or loss of hearing occurs
  • •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
  • •any new symptoms occur

    • These could be signs of a serious condition


If Pregnant Or Breast-Feeding,



ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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
  • •drink a full glass of water with each dose
  • •adults and children 12 years of age and over: take 2 geltabs every 6 hours; not more than 8 geltabs 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



black iron oxide, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



GOODSENSE®

Extra Strength

See New Warning

Headache Relief

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

80 Geltabs

Compare to active ingredients of Excedrin® Extra Strength

headache relief image - image 01

headache relief image - image 01


* Please review the disclaimer below.