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  5. Label Information: Dual Action Complete

FDA Label for Dual Action Complete

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CHEWABLE TABLET)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    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. PRINCIPAL DISPLAY PANEL

Dual Action Complete Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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 Chewable Tablet)



Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg


Purpose



Acid reducer

Antacid


Use



relieves heartburn associated with acid indigestion and sour stomach


Warnings



Allergy alert: Do not use if you are allergic to famotidine or other acid reducers


Do Not Use



  • •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • •with other acid reducers

Ask A Doctor Before Use If You Have



  • •had heartburn over 3 months. This may be a sign of a more serious condition.
  • •heartburn with lightheadedness, sweating, or dizziness
  • •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • •frequent chest pain
  • •frequent wheezing, particularly with heartburn
  • •unexplained weight loss
  • •nausea or vomiting
  • •stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are



presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Stop Use And Ask A Doctor If



  • •your heartburn continues or worsens
  • •you need to take this product for more than 14 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 (1-800-222-1222).


Directions



  • •adults and children 12 years and over:
  • •do not swallow tablet whole: chew completely
  • •to relieve symptoms, chew 1 tablet before swallowing
  • •do not use more than 2 chewable tablets in 24 hours
  • •children under 12 years: ask a doctor

Other Information



  • •each tablet contains: calcium 330 mg; magnesium 70 mg
  • •Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet
  • •read the directions and warnings before use
  • •read the bottle label. It contains important information.
  • •store at 20-25°C (68-77°F)
  • •protect from moisture

Inactive Ingredients



anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to Pepcid Complete® active ingredients

Berry Flavor

Dual Action Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets (Chewable)

Acid Reducer + Antacid

Just One Tablet Relieves Heartburn Due to Acid Indigestion

50 Chewable Tablets

Actual Size


* Please review the disclaimer below.