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  5. Label Information: Rulox Regular

FDA Label for Rulox Regular

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?

Rulox Regular Product Label

The following document was submitted to the FDA by the labeler of this product Tya Pharmaceuticals. 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 Teaspoonful)



Aluminum hydroxide 200 mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg


Purposes



Antacid Antigas



Uses



relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas

Warnings



• kidney disease • a magnesium-restricted diet taking a prescription drug. Antacids may interact with certain prescription drugs. symptoms last more than 2 weeks Ask a doctor before use if you have


Ask a doctor or pharmacist before use if you are



Stop use and ask a doctor if


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



• shake well before use • adults and children 12 years and older: take 2 to 4 teaspoonfuls four times a day, or as directed by a doctor • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor




Other Information



• magnesium 85 mg, sodium 1 mg • store at room temperature each 5 mL teaspoonful contains:

• protect from freezing  • keep tightly closed

• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.


Inactive Ingredients



benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution


Questions Or Comments?



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