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  5. Label Information: Antacid Double Strength

FDA Label for Antacid Double Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML) (ONE TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS

Antacid Double Strength Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. 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 5 Ml) (One Teaspoonful)



Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 mg


Purpose



Antacid

Antigas


Uses



relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •associated symptoms of gas and upset stomach
  • •overindulgence of food and drink

Ask A Doctor Before Use If You Have



  • •kidney disease
  • •a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



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


Stop Use And Ask A Doctor If



symptoms last for more than 2 weeks


Keep Out Of Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center immediately.


Directions



  • •shake well before each use
  • •adults and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
  • •do not take more than 12 teaspoonsful in 24 hour period
  • • do not use the maximum dosage for more than 2 weeks
  • •children under 12 years: ask a doctor

Other Information



  • •TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
  • •Store at room temperature 15° - 30°C (59° - 86°F)
  • •keep tightly closed
  • •protect from freezing
  • •each teaspoon (5 mL) contains: magnesium 165 mg
  • •each teaspoon (5 mL) contains: sodium 1 mg
  • •does not meet USP requirements for preservative effectiveness

Inactive Ingredients



flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, xanthan gum and water


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