FDA Label for Regular Strength Antacid Anti Gas

View Indications, Usage & Precautions

Regular Strength Antacid Anti Gas Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets 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 10 Ml)



Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg


Purposes



Antacid

Antigas


Uses



relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •upset stomach due to these symptoms
  • •pressure and bloating commonly referred to as gas

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.


When Using This Product



do not exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor


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



  • •shake well before use
  • •measure with dosing cup provided
  • •adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
  • •do not take more than 120 mL in any 24 hour period
  • •do not use the maximum dosage for more than 2 weeks
  • •children under 12 years: ask a doctor
  • •mL = milliliter

Other Information



  • •each 10 mL contains: magnesium 175 mg
  • •does not meet USP requirements for preservative effectiveness
  • •store at 20-25°C (68-77°F), do not freeze

Inactive Ingredients



butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution


Principal Display Panel



ANTACID/ANTI-GAS

regular strength

ORIGINAL FLAVOR

Soothing relief of

heartburn

acid indigestion

sour stomach

ALCOHOL 0.2%

12 FL OZ (355 mL)


* Please review the disclaimer below.