1. Home
  2. Labeler Index
  3. Chain Drug Marketing Association
  4. 63868-712
  5. Label Information: Regular Strength Antacid

FDA Label for Regular Strength Antacid

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?
    10. PACKAGE LABEL

Regular Strength Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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



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 more than 2 weeks

If pregnant or breast-feeding, ask a health professional before use.


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 between meals, at bedtime, or as directed by a doctor

• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• children under 12 years: ask a doctor


Other Information



• each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg

• store at room temperature

• protect from freezing

 • keep tightly closed


Inactive Ingredients



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


Questions Or Comments?



1-800-540-3765


Package Label



NDC 63868-712-57

QUALITY CHOICE

*Compare to the Active Ingredients in Mylanta® Regular Strength

Regular Strength

Antacid

Antigas, Fast Acting

Alumina, Magnesia and Simethicone Oral Suspension USP

Fast Soothing Relief of:
Acid Indigestion
Heartburn
Sour Stomach
Pressure and Bloating

Alcohol: less than 0.5%

Original Flavor

12 FL OZ (355 mL)



* Please review the disclaimer below.