Active Ingredients (In Each 5 Ml Teaspoonful)
Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg
Almacone Double Strength Suspension
FDA Label NDC 0536-0015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Almacone Double Strength (NDC 0536-0015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antacid
Antigas
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms of 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
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 12 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 165 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
Questions Or Comments?
1-800-645-2158
Package Label
Rugby
NDC 0536-0015-83
Almacone
DOUBLE STRENGTH
Alumina, Magnesia and Simethicone Oral Suspension USP
Antacid
Antigas
VERY LOW SODIUM
12 FL OZ (355 mL)
compare to active ingredients in MYLANTA EXTRA STRENGTH
Alcohol: 0.5%
* Please review the disclaimer below.
