FDA Label for Mi-acid Regular Strength
View Indications, Usage & Precautions
Mi-acid Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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
• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.
Inactive Ingredients
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
Principal Display Panel - 355 Ml Bottle Label
CommUnityCare Federally Qualified Health Centers
MI-ACID
ALT
MAALOX
R.S.
355ML
Date:
Name:
Dr.
USE AS DIRECTED. (Alternative for Maalox R.S.)
123456
1/1/01
MI-ACID REG. STRENGTH 355ML NDC 76413-319-01
Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
* Please review the disclaimer below.