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  5. Label Information: Good Sense Dual Action

FDA Label for Good Sense Dual Action

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    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. WHEN USING THIS PRODUCT
    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. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Good Sense Dual Action 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 Caplet)



Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever


Uses



  • •temporarily relieves minor aches and pains due to:
  • •headache
  • •toothache
  • •backache
  • •menstrual cramps
  • •muscular aches
  • •minor pain of arthritis

Warnings



Acetaminophen liver damage warning:

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

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

    • Acetaminophen allergy alert: may cause severe skin reactions.

    Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash

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

      NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to

      aspirin.

      Symptoms may include:

      • •hives
      • •facial swelling
      • •asthma (wheezing)
      • •shock
      • •skin reddening
      • •rash
      • •blisters

        • If an allergic reaction occurs, stop use and seek medical help right away.

        NSAID 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

          • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.


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 have ever had an allergic reaction to acetaminophen or any other pain reliever
  • •right before or after heart surgery

Ask A Doctor Before Use If



  • •you have liver disease
  • •stomach bleeding warning applies to you
  • •you have problems or serious side effects from taking pain relievers
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • •you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are



  • •under a doctor’s care for any serious condition
  • •taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • •taking any other drug

When Using This Product



  • •take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If



  • •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
  • •you have symptoms of heart problems or stroke:
  • •chest pain
  • •trouble breathing
  • •weakness in one part or side of body
  • •slurred speech
  • •leg swelling
  • •pain gets worse or lasts more than 10 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear

If Pregnant Or Breast-Feeding,



ask a health professional before use. It is especially important not to use ibuprofen 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). Prompt 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 directed

    • Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist

    Children under 12 years: ask a doctor

    • •do not take more than 6 caplets in 24 hours, unless directed by a doctor

Other Information



  • •read all warnings and directions before use. Keep carton.
  • •store at 20-25°C (68-77°F)
  • •avoid excessive heat above 40°C (104°F)

Inactive Ingredients



colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



GOODSENSE®

Acetaminophen plus Ibuprofen

CONTAINS 2 MEDICINES

Dual Action

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144 Caplets**

**Capsule-Shaped Tablets

Compare to active ingredients of Advil® Dual Action

dual action-image 1 - image 01

dual action-image 1 - image 01


* Please review the disclaimer below.