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  5. Label Information: Antacid

FDA Label for Antacid

View Indications, Usage & Precautions

Table of Contents

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

Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 )



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


Purpose



Antacid
Antacid
Antigas


Use(S)



relieves:


  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach and gas associated with these symptoms 

Warnings



Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.


Ask A Doctor Before Use If You Have



  • kidney disease
  • a magnesium-restricted diet

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 Doctor



if symptoms last more than two weeks


Keep Out Of Reach Of Children



.


Directions



  • shake well before use
  • mL = milliliter
  • adults and children 12 years and older: take 10 mL to 20 mL two times a day, or as directed by a doctor
  • children under 12 years: consult a doctor

Other Information



  • each 5 mL contains: magnesium 85 mg, sodium 5 mg
  • store at controlled room temperature 20°C-25°C (68°-77°F)
  • do not freeze

Inactive Ingredients



ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol


Principal Display Panel



Rugby

NDC 0536-1293-83

Regular Strength
Antacid Liquid
Aluminum hydroxide
Magnesium hydroxide
Simethicone
200 mg/200 mg/ 20 mg

 

Antacid and Antigas
Original Flavor

Relief of:

Heartburn

Acid Indigestion

Sour Stomach

Pressure & Bloating


12 FL OZ (355 mL)
Alcohol content 0.2% v/v







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