FDA Label for Advanced Antacid Regular Strength
View Indications, Usage & Precautions
Advanced Antacid Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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 200mg (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 under 12 years: ask a doctor
Other Information
- each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg
- protect from freezing
- store at room temperature
- keep tightly closed
Inactive Ingredients
benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
Package Label
Sunmark
compare to active ingredients of the Regular Strength Mylanta®*
NDC 49348-153-39
advanced
antacid
Regular Strength
antacid/antigas
Alumina, Magnesia
and Simethicone
Oral Suspension
Fast acting
soothing relief of
heartburn,
acid indigestion,
sour stomach,
pressure & bloating
ORIGINAL FLAVOR
Alcohol 0.15%
12 FL OZ (355 mL)
* Please review the disclaimer below.