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SIMETHICONE (dimethicone 125 mg) Dailymed

  1. Human OTC
  2. Gastric Medications,other
  3. SPIRIT PHARMACEUTICALS,LLC

Generic: dimethicone is used for the treatment of Flatulence

SIMETHICONE solution - (dimethicone 125 mg) image

IMPRINT: P10     SHAPE: oval
    COLOR: green

  1. FDA Adverse Reactions

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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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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"

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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