Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0), MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Topco Associates LLC
ORAL
OTC DRUG
Antacid Antigas for the relief of
OTC monograph final
TOPCARE ANTACID MAXIMUM STRENGTH- ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE SUSPENSION TOPCO ASSOCIATES LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- TOPCO ASSOCIATES LLC. ANTACID DRUG FACTS ACTIVE INGREDIENTS (IN EACH 10 ML) Aluminum hydroxide (equiv. to dried gel, USP) 800 mg Magnesium hydroxide 800 mg Simethicone 80 mg PURPOSE Antacid Antigas USES for the relief of • • • • • WARNINGS ASK A DOCTOR BEFORE USE IF YOU HAVE • • 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 take more than 40 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician acid indigestion heartburn sour stomach upset stomach associated with these symptoms pressure and bloating commonly referred to as gas kidney disease a magnesium-restricted diet KEEP OUT OF REACH OF CHILDREN. DIRECTIONS • • • • • OTHER INFORMATION • • • • INACTIVE INGREDIENTS butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution QUESTIONS OR COMMENTS? 1-888-423-0139 PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH Antacid Advanced ANTACID & ANTIGAS OUR PHARMACISTS RECOMMEND FAST RELIEF Heartburn Acid Indigestion Pressure Bloating (Gas) ALCOHOL 0.1% 12 FL OZ (355 mL) shake well before using only use the dose cup provided adults and children 12 years and older: take 10 mL to 20 mL two times a day or as directed by a physician do not take more than 40 mL in 24 hours or use the maximum dosage for more than 2 weeks children under 12 years: consult a physician EACH 10 ML CONTAINS: magnesium 350 mg and sodium 3 mg does not meet USP requirements for preservati Read the complete document