Active Ingredients(In Each 30 Ml Cup)
Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg | Antacid |
Magnesium hydroxide 1200 mg | Antacid |
Simethicone 120 mg | Antigas |
Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone Suspension
FDA Label NDC 60687-877
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone (NDC 60687-877). 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 30 ml cup), purpose, uses, warnings, 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, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid/Antigas
Uses
for the relief of:
- acid indigestion
- heartburn
- sour stomach
- upset stomach due to these symptoms
- pressure and bloating commonly referred to as gas
Warnings
Do not take more than 4 unit dose cups (120 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.
Ask A Doctor Before Use If You Have
- kidney disease
- a magnesium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop Use And Ask A Doctor If
symptoms last more than 2 weeks.
Directions
- shake well before using
- do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks
adults and children 12 years and older | Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor. |
children under 12 years | consult a physician |
Other Information
- each 30 mL contains: magnesium 498 mg, sodium 8.04 mg
- Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
- protect from freezing
- White colored, peppermint flavored liquid supplied in the following oral dosage form:
- 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76
Inactive Ingredients
Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium , and sorbitol solution.
Questions Or Comments?
Call 1-800-845-8210
DO NOT USE IF SEAL IS BROKEN.
Distributed By:
American Health Packaging
Columbus, OH 43217
R01/25
Principal Display Panel – Tray Label
Case NDC 60687-877-76/Cup NDC 60687-877-45
Magnesium Hydroxide,
Aluminum Hydroxide, and
Simethicone Suspension
Antacid/Antigas
1200 mg/1200 mg/120 mg per 30 mL
Sugar Free
SHAKE WELL
USUAL DOSAGE: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
Protect from freezing.
For Institutional Use Only
T1761C300125 R01/25
Principal Display Panel – Cup – 1200 Mg/1200 Mg/120 Mg 30 Ml
NDC 60687- 877-45
Magnesium Hydroxide,
Aluminum Hydroxide, and
Simethicone Suspension
Antacid/Anti-Gas
1200 mg/1200 mg/120 mg per 30 mL
Sugar Free
Delivers 30 mL
SHAKE WELL/Protect from freezing
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F1761C300125
* Please review the disclaimer below.
