SIMETHICONE
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- SPIRIT PHARMACEUTICALS,LLC
- Label updated
- 2010-02-09
- Retrieved
- 2026-09-07
- Active ingredients
- DIMETHICONE
Label information
Drug Facts
Active ingredient (per softgel)
Simethicone 125 mg
Purpose
Antigas
Use
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings
Label information
Keep out of reach of children.
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other information
- store at a controlled room temperature 20-25°C (68-77°F)
- protect from light, heat and moisture
Inactive ingredients
D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide
PRINCIPAL DISPLAY PANEL - 125 mg Label
SIMETHICONE CAPSULES USP 125MG
Each Softgel Contains:
(Simethicone USP 125 mg)
| LOT NO | : | QUANTITY | : | ||
| DRUM NO | : | NDC NO | : 68210-1901- | ||
| MFG DATE | : | EXP DATE | : |
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D&C ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
[Image in the official label — see DailyMed source]
DailyMed Set ID: 79eb60b1-f651-4f9c-8d20-a8eacfcfbbe8 · Version 1
NDC: 68210-1901