FDA-filed SPL labeling · retrieved through openFDA

Simethicone

Simethicone is an anti-gas ingredient used across many oral products to relieve the pressure, bloating, and discomfort caused by trapped gas — including infant formulas specifically designed for babies.

Brand names Maalox Anti-GasSonoRxPhazymeMytab GasMylicon +11 more
Drug class Skin Barrier Activity
OTC Forms 6 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 311 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 10, 2025
Clinical labels in scope 311
AvailabilityOTC
Earliest approval/marketing year 1997
FDA-listed product records 782
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 20, 2026
Simethicone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Simethicone is a widely used, over-the-counter ingredient that helps relieve trapped gas, bloating, and pressure in both adults and infants. It comes in several forms — including capsules, chewable tablets, and infant drops — so there's an option for most ages. Always use the dose and measuring device that match your specific product, and call Poison Control at 1-800-222-1222 if you suspect an overdose.

📖 Simethicone: Patient Information Guide

A plain-language walkthrough of Simethicone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Simethicone is used to relieve uncomfortable gas symptoms across a wide range of oral products. Here's what the available products are approved to treat:

  • Pressure, bloating, and fullness commonly referred to as gas — covered by capsule and chewable tablet products including Gas-X, Antigas, Anti-Gas, CVS Health Gas Relief SOFTGEL, FEVIA Gas Control, Discount Drugmart Gas Relief, Extra Strength Gas Relief, Kroger Extra Strength, Gas Relief - Cherry Flavor, and Gas Relief SIMETHICONE 250 mg Anti-gas
  • Bloating, pressure, fullness, and stuffed feeling commonly referred to as gas — covered by Pepto capsules and chewable tablets
  • Bloating, pressure, and discomfort from gas caused by certain foods or air swallowing — covered by Gas Relief chewable tablets
  • Gas discomfort in infants frequently caused by air swallowing or certain formulas or foods — covered by infant-specific products including Mylicon Infants Gas Relief, Walgreens Infants Dye Free Gas Relief, Publix Infants Dye Free, Meijer Infants Gas Relief Drops, and similar infant drops and suspensions
  • Symptoms of gas in children and infants frequently caused by air swallowing or certain formulas or foods — covered by infant oral solution and suspension products including Gas-Aid Drops for infants, CVS Health Infant, Best Choice, Infants Gas Relief, and similar products
💊How it's taken

Simethicone is taken by mouth and comes in several forms — including capsules, chewable tablets, oral solutions, and oral suspensions (drops). Adult and older-child products are generally taken after meals and at bedtime. Infant drop products should always be shaken well before use, measured with only the enclosed syringe or dropper, and can be repeated as needed after meals and at bedtime — but no more than 12 doses per day.

  • The infant dose can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids if needed
  • Always use the measuring device included with the infant product — not a different syringe, dropper, or spoon
  • Follow your product's specific label or your doctor's instructions for the right timing and amount
🤒Side effects — in detail

The FDA product labels for simethicone do not list specific common side effects. However, if something unexpected happens after taking it, contact your doctor or pharmacist.

    In case of overdose, call Poison Control immediately at 1-800-222-1222 or seek emergency medical help — even if no symptoms are visible yet.

    ⚠️Warnings & precautions
    • Keep all simethicone products out of reach of children.
    • If you suspect an overdose, call Poison Control right away at 1-800-222-1222 or get emergency medical help — quick action is important even without visible symptoms.
    • For infant drops and suspensions, always use only the measuring device included with the product; using another device can result in an incorrect dose.
    🔀What it interacts with

    The available FDA product labels for simethicone do not identify specific drug, food, or substance interactions.

      This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

      📋Before taking it
      • Keep all simethicone products stored safely out of children's reach.
      • For infant products, only use the enclosed syringe or dropper to measure doses — never substitute another device.
      • Consult your doctor or pharmacist if you are unsure which simethicone product or form is appropriate for yourself or your child.
      🚑If you take too much

      If you think someone has taken too much simethicone, call Poison Control right away at 1-800-222-1222 or go to an emergency room immediately. The label is clear: get help fast — even if the person looks and feels fine, because signs or symptoms may not appear right away.

      📦How to store it

      store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture

      📄 Written from Simethicone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

      17

      Supplements & herbs that interact with Simethicone

      17 supplements and herbal products have documented interactions with Simethicone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

      Severity mix
      • Major · 1
      • Moderate · 7
      • Minor · 9
      Every supplement checked against Simethicone — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Simethicone against your exact supplements

      Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

      🩺 Pharmacist Counseling Corner

      Quick, plain-English answers to the questions patients ask most about Simethicone — the kind of thing our pharmacy team would talk through with you at the counter.

      What exactly does simethicone do for gas?
      Simethicone works to relieve the uncomfortable pressure, bloating, and full or stuffed feeling that comes from trapped gas in your stomach or intestines. It's used when gas builds up from eating certain foods or from swallowing air. It won't prevent gas from forming, but it helps ease the discomfort once it's there.
      Can I give simethicone drops to my baby?
      Yes — there are infant-specific simethicone products, like Mylicon Infants Gas Relief and similar infant drops, designed just for babies. They're used to relieve gas discomfort that can happen from air swallowing or certain formulas or foods. Always use the syringe or dropper that comes in the box — never a different one — and don't give more than 12 doses in a day.
      How often can I (or my baby) take it?
      For infant drops and suspensions, you can repeat the dose as needed after meals and at bedtime — but stop at 12 doses per day. For adult capsules and chewable tablets, the general guidance is after meals and at bedtime, or as your doctor directs. Always follow the directions on your specific product's label.
      Can I mix the baby drops into formula or water?
      Yes, the infant drops can be mixed into about 1 oz. of cool water, infant formula, or another suitable liquid if that makes it easier to give. Just make sure you still measure the dose carefully with the enclosed syringe or dropper before mixing it in.
      What should I do if too much is taken by accident?
      Call Poison Control right away at 1-800-222-1222 or go to an emergency room immediately. The label is clear that quick action matters — even if the person looks and feels completely fine, because signs of a problem may not show up right away. Don't wait to see if symptoms appear.
      Are there any foods, medications, or other products I need to avoid while taking simethicone?
      The product labels for simethicone don't call out specific drug interactions or foods to avoid. That said, it's always a good idea to mention all the medications and supplements you take to your pharmacist — they can double-check for you.
      Is Simethicone available over the counter?
      Yes — Simethicone is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
      When was Simethicone first available?
      Simethicone has been available in the United States since at least 1997, based on FDA approval history (Drugs@FDA) and product marketing records.
      Who makes Simethicone?
      Simethicone is supplied by 175 manufacturers listed in the FDA NDC Directory, including Strategic Sourcing Services Llc, Spirit Pharmaceuticals LLC, Walgreens.

      💬 Answers drafted from Simethicone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

      🧰 Keep exploring

      💊 How Simethicone comes

      Simethicone is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

      Capsule

      By mouth
      Brands Gas-X Phazyme
      How this form is used
      What it may be used for
      • Anti-Gas is used for relief of pressure, bloating, and fullness commonly referred to as gas.
      • Antigas is used for relief of pressure, bloating, and fullness commonly referred to as gas.
      • CVS Health Gas Relief SOFTGEL is used for relief of pressure, bloating, and fullness commonly referred to as gas.
      • FEVIA Gas Control is used for relief of pressure, bloating, and fullness commonly referred to as gas.
      Important instructions
      • Take by mouth as directed on the product label or by your doctor.
      • These products are typically taken after meals and at bedtime.
      • Follow your specific product's label for dosing guidance.
      Available strengths 5 strengths
      459 FDA-listed product records

      Chewable tablet

      By mouth
      Brands Gas-X
      How this form is used
      What it may be used for
      • Gas-X chewable tablets are used for relief of pressure, bloating, and fullness commonly referred to as gas.
      • Gas Relief chewable tablets are used to relieve bloating, pressure, and discomfort from gas caused by certain foods or air swallowing.
      • Pepto chewable tablets are used to relieve bloating, pressure, fullness, and stuffed feeling commonly referred to as gas.
      • Kroger Extra Strength chewable tablets are used for relief of pressure, bloating, and fullness commonly referred to as gas.
      Important instructions
      • Chew tablets thoroughly before swallowing, as directed on the product label.
      • Take after meals and at bedtime, or as directed by a doctor.
      • Follow your specific product's label for dosing guidance.
      Available strengths 3 strengths
      198 FDA-listed product records

      Oral solution

      By mouth
      Brands Best Choice CVS Health Anti gas CVS Health Infant Gas-Aid Drops for infants Infants Infants Gas relief
      How this form is used
      What it may be used for
      • Gas-Aid Drops for infants is used to relieve symptoms of gas in infants frequently caused by air swallowing or certain formulas or foods.
      • Infants Gas relief oral solution is used to relieve symptoms of gas frequently caused by air swallowing or certain formulas or foods.
      Important instructions
      • Shake well before each use.
      • Use only the enclosed syringe or dropper — never a different measuring device.
      • Doses may be repeated as needed after meals and at bedtime, or as directed by a physician.
      • Do not exceed 12 doses per day. The dose can also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.
      Available strengths 4 strengths
      74 FDA-listed product records

      Oral suspension

      By mouth
      Brands Mylicon
      How this form is used
      What it may be used for
      • Mylicon infant suspension is used to relieve the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.
      • Infants Gas Relief suspension is used to relieve symptoms of gas frequently caused by air swallowing or certain formulas or foods.
      Important instructions
      • Shake well before each use.
      • Use only the enclosed syringe or dropper — do not use any other measuring device.
      • Dispense the liquid slowly into the baby's mouth toward the inner cheek.
      • Doses may be repeated as needed after meals and at bedtime, but do not exceed 12 doses per day. The dose can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.
      Available strengths 1 strength
      43 FDA-listed product records

      Other oral form

      By mouth
      Brands Gas Relief SIMETHICONE 250 mg Anti-gas
      How this form is used
      What it may be used for
      • Gas Relief SIMETHICONE 250 mg Anti-gas is used for relief of pressure, bloating, and fullness commonly referred to as gas.
      Important instructions
      • Take by mouth as directed on the Gas Relief SIMETHICONE 250 mg Anti-gas product label or by your doctor.
      Available strengths 2 strengths
      4 FDA-listed product records

      Topical cream, ointment or gel

      By mouth
      Available strengths 1 strength
      2 FDA-listed product records

      📊 Simethicone across the U.S. market

      How Simethicone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

      6
      Dose forms
      175
      Manufacturers
      40
      Brand names
      782
      FDA-listed product records
      1997
      First marketed

      FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

      Also listed with the FDA, not a patient dose form: Kit (1) · Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

      Strategic Sourcing Services Llc7%
      Spirit Pharmaceuticals LLC5%
      Walgreens5%
      Rite Aid Corporation4%
      Best Choice (valu Merchandisers Company)4%
      CVS Pharmacy4%
      Other makers71%

      Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

      📈 How widely Simethicone is used

      A general measure of how commonly Simethicone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

      Think of this as a proxy for how widely Simethicone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

      219,250
      Medicaid prescriptions filled (Q1–Q4 2025)
      $3.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

      How commonly is Simethicone prescribed? Of the 1,596 medications we measure, Simethicone ranks #377 by Medicaid prescriptions — more than 76% of them.

      Where Simethicone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

      Utilization by Simethicone product

      Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

      The 80 mg chewable tablet is the most-dispensed Simethicone product — about 50% of these Medicaid prescriptions.

      simethicone 80 MG Chewable Tablet Most dispensed

      109,483 Medicaid prescriptions (Q1–Q4 2025) 50% of Simethicone prescriptions shown $926,278 gross reimbursement (before rebates) ≈ $8.46 per prescription (gross)

      Summed across the 5 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314216

      simethicone 66.7 MG/ML Oral Suspension

      56,034 Medicaid prescriptions (Q1–Q4 2025) 26% of Simethicone prescriptions shown $2M gross reimbursement (before rebates) ≈ $35 per prescription (gross)

      Summed across the 4 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198857

      simethicone 125 MG Chewable Tablet

      32,677 Medicaid prescriptions (Q1–Q4 2025) 15% of Simethicone prescriptions shown $325,391 gross reimbursement (before rebates) ≈ $9.96 per prescription (gross)

      Summed across the 4 of 94 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314221

      simethicone 125 MG Oral Capsule

      14,110 Medicaid prescriptions (Q1–Q4 2025) 6% of Simethicone prescriptions shown $113,433 gross reimbursement (before rebates) ≈ $8.04 per prescription (gross)

      Summed across the 3 of 145 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198852

      simethicone 180 MG Oral Capsule

      6,946 Medicaid prescriptions (Q1–Q4 2025) 3% of Simethicone prescriptions shown $54,586 gross reimbursement (before rebates) ≈ $7.86 per prescription (gross)

      Summed across the 5 of 125 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 252294

      Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

      Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Simethicone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 521 listed Simethicone NDCs with Medicaid activity.

      🔍 Compare Simethicone products

      A representative set of FDA-listed product records for Simethicone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

      Showing 200 of 782 products — FDA National Drug Code Directory. See every product, package size and price: browse all 782 Simethicone NDCs →

      RxNorm Concept Web — From Ingredient to Every Form and Strength

      This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

      Ingredient (IN) Simethicone RxCUI 9796 6 dose forms · 16 strengths
      1. Dose form (SCDF) Chewable Tablet RxCUI 373881 In current FDA listings
        Clinical drug / strength (SCD) 42 MG RxCUI 433906 80 MG RxCUI 314216 125 MG RxCUI 314221 166 MG RxCUI 312957 250 MG RxCUI 2595235
      2. Dose form (SCDF) Oral Capsule RxCUI 373880 In current FDA listings
        Clinical drug / strength (SCD) 100 MG RxCUI 199971 125 MG RxCUI 198852 180 MG RxCUI 252294 250 MG RxCUI 412111 500 MG RxCUI 2477951
      3. Dose form (SCDF) Oral Film RxCUI 2269676 No current FDA listing
        Clinical drug / strength (SCD) 62.5 MG RxCUI 705156
      4. Dose form (SCDF) Oral Solution RxCUI 373884 In current FDA listings
        Clinical drug / strength (SCD) 8.4 MG/ML RxCUI 142065
      5. Dose form (SCDF) Oral Suspension RxCUI 373883 In current FDA listings
        Clinical drug / strength (SCD) 25 MG/ML RxCUI 2262288 40 MG/ML RxCUI 245368 66.7 MG/ML RxCUI 198857
      6. Dose form (SCDF) Oral Tablet RxCUI 373885 No current FDA listing
        Clinical drug / strength (SCD) 125 MG RxCUI 198853

      Look up RxCUI 9796 in the RxCUI Atlas →

      RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

      🏷️ Sold under these brand names

      Maalox Anti-Gas SonoRx Phazyme Mytab Gas Mylicon Mylaval Mylanta Gas Micon-80 Majorcon Alka-Seltzer Anti-Gas Genasyme Gas-X Gas Aide Flatulex Drops Degas Colicon

      🏭 Manufacturers & labelers

      Strategic Sourcing Services Llc 31 Spirit Pharmaceuticals LLC 23 Walgreens 21 Rite Aid Corporation 17 Best Choice (valu Merchandisers Company) 17 CVS Pharmacy 16 PuraCap Pharmaceutical LLC 14 Cvs 14 P & L Development, LLC 13 Kroger Company 13 H E B 12 Target Corporation 12 Walgreen Co. 11 Geri-Care Pharmaceuticals, Corp 11 Allegiant Health 11 United Natural Foods, Inc. dba UNFI 10 Quality Choice (chain Drug Marketing Association) 9 Safeway 9 Cardinal Health 9 Shield Pharmaceuticals Corp 9 WinCo Foods, LLC 9 Meijer, Inc. 9 Aphena Pharma Solutions - Tennessee, LLC 9 TOP CARE (Topco Associates LLC) 9

      …and 16 more on the FDA NDC directory.

      🔬 Where this comes from

      Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

      📄
      FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 10, 2025
      🏭
      Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Simethicone.
      📈
      Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
      🚨
      Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
      🧾 Clinical label set — FDA-filed SPL labels retained for Simethicone after exact ingredient or ingredient-combination matching and applicable route/form matching
      Clinical labels in scope
      311
      NDC products indexed
      782
      Distinct labelers/manufacturers represented
      175
      Linked representative label
      Aphena Pharma Solutions - Tennessee, LLC
      Linked label effective
      Jan 10, 2025
      Composite sections available
      8
      Linked SPL Set ID
      5df94be7-0bc9-4be1-9982-8193e3a3c8ef
      Linked SPL Document ID
      2b5afc84-182d-07ef-e063-6294a90a9f3e
      Open the linked representative label on DailyMed ↗
      NDC package records associated with this linked SPL 1

      How we combine label and product data

      HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 311 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

      For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Aphena Pharma Solutions - Tennessee, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

      This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.