Active Ingredients (In Each Tablet)
Aluminum hydroxide dried gel 200 mg
Magnesium hydroxide 200 mg
Simethicone 25 mg
Gelusil Tablet, Chewable
FDA Label NDC 65197-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Gelusil (NDC 65197-300). 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 tablet), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, keep out of reach of children., if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Active ingredients (in each tablet) Purpose
Aluminum hydroxide dried gel 200 mg........................Antacid
Magnesium hydroxide 200 mg....................................Antacid
Simethicone 25 mg......................................................Antigas
Uses
Relieves:
- Heartburn
- Sour stomach
- Acid indigestion
- Bloating, pressure and discomfort commonly referred to as gas
Ask A Doctor Before Use If You Have
- Kidney disease
- A magnesium restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
now taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop Use And Ask A Doctor If
symptoms last more than 2 weeks
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away 1.800.222.1222
If Pregnant Or Breastfeeding
ask a health professional before use.
Directions
- Adults and children 12 years of age and older: Chew 2 to 4 tablets. Repeat hourly if symptoms return, or as directed by a physician
- Children under 12 of age: ask a doctor
- Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician
Other Information
- Each tablet contains: magnesium 95 mg
- Store below 30°C (86°F)
- Tamper Evident. Do not use if blister or printed Gelusil foil seal is broken
- See end panel for lot number and expiration date
Inactive Ingredients
Dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose
Questions?
Call 1-844-241-5454
© WellSpring 2018
Sarasota, FL 34243 USA
Made in USA
Principal Display Panel - Carton
Gelusil Antacid Antigas 10 Blister (Gelusil 1)
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