REGULAR STRENGTH ANTACID/ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone 400 mg/10mL; 400 mg/10mL; 40 mg/10mL Suspension, 355 mL — NDC 00536-1317-83 package photo

REGULAR STRENGTH ANTACID/ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone 400 mg/10mL; 400 mg/10mL; 40 mg/10mL Suspension, 355 mL

by RUGBY LABORATORIES · 355 mL in 1 BOTTLE (0536-1317-83)
NDC 00536-1317-83
🏷️ FDA NDC (as labeled) 0536-1317-83 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0536-1317-83
Product NDC 0536-1317
11-digit billing NDC 00536131783
NCPDP billing unit ML — per mL (volume)
RxCUI 307746
UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O
Application # M001
SPL Set ID b244fce9-9626-e947-e053-2995a90ab8f9
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-01
Route ORAL
Dosage form SUSPENSION
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
GPI-14 48991003101810
GPI class Antacid/Antigas
GCN Seq No 002701
GCN 63910
HICL code 001168
Ingredient (HICL) Mag Hydrox/Aluminum Hyd/Simeth
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name ANTACID-ANTIGAS LIQUID
FDB brand name Antacid-Antigas
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1317-83 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00536-1317-83. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Aluminium compounds class.

Drug family (ATC) Aluminium compounds
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRUGBY LABORATORIES
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedAug 2020
Product typeHuman Otc Drug
Portfolio149 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ANTACID-ANTIGAS LIQUID Ingredient Mag Hydrox/Aluminum Hyd/Simeth
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter antacid suspension taken by mouth. It contains two antacids, aluminum hydroxide and magnesium hydroxide, which are typically used to neutralize stomach acid and relieve heartburn and indigestion. The product also contains dimethicone, an ingredient commonly used in antacid formulas to reduce gas and bloating by helping break up gas bubbles in the stomach and intestines.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbenzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.011 $3.73 / 355 ml
Medicaid paysCMS SDUD · 12 mo $0.0312 $11.08 / 355 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.011 $0.007
▲ Up 30% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 00536-1293-83 Rugby 355 ml $0.010 Availability likely
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mLthis 00536-1317-83 RUGBY 355 ml $0.010 Availability likely
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0433-40 AMERISOURCEBERGEN 355 ml $0.010 Availability likely
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0434-40 AMERISOURCEBERGEN 355 ml $0.010 Availability likely
Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 70000-0063-01 CARDINAL 355 ml $0.010 Availability likely
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1063-01 STRATEGIC 355 ml $0.010 Availability likely
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1066-01 STRATEGIC 355 ml $0.010 Availability likely
QCH Regular Strength Antacid 509 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0121-12 Chain 355 ml $0.010 Availability likely
Antacid Mint 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0694-57 Chain 355 ml $0.011 FDA listed +2%
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0712-57 Chain 355 ml $0.011 FDA listed +2%
Mag-AL Plus 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 00121-1761-30 PAI 10 cups FDA listed
Advanced Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-1639-12 WALGREEN 355 ml FDA listed
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-2628-12 WALGREEN 355 ml FDA listed
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 00904-7557-73 Major 10 cups FDA listed
Regular Strength Antacid And Gas Relief 200 mg/5mL; 20 mg/5mL; 200 mg/5mL 11822-3324-07 RITE 355 ml Discontinued
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 17856-0630-01 ATLANTIC 50 cups FDA listed
Antacid Plus 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 21130-0629-12 BETTER 355 ml FDA listed
Melox 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 27854-0115-01 Belmora 355 ml FDA listed
Melox 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 27854-0117-01 Belmora 355 ml FDA listed
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0637-12 KROGER 355 ml FDA listed
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0639-12 KROGER 355 ml FDA listed
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 36800-0582-40 Topco 355 ml FDA listed
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0099-12 H 355 ml FDA listed
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0554-05 H 355 ml FDA listed
Geri-Lanta Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 50090-4259-00 A-S 355 ml FDA listed
Antacid And Gasrelief 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0629-12 GOODSENSE 355 ml FDA listed
Advanced Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0639-12 GOODSENSE 355 ml FDA listed
Mag-Al Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 55154-9429-05 Cardinal 5 cups FDA listed
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 57237-0316-31 Rising 100 cups FDA listed
Ko-Lanta 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0004-12 Geri-Care 355 ml FDA listed
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0629-06 Geri-Care 177 ml Discontinued
Geri-Mox Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0639-12 Geri-Care 355 ml FDA listed
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 60687-0877-76 American 10 cups FDA listed
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0629-12 VALU 355 ml FDA listed
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0639-12 VALU 355 ml FDA listed
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68071-5289-01 NuCare 355 ml FDA listed
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-7841-03 Preferred 355 ml FDA listed
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-8169-03 Preferred 355 ml FDA listed
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68788-8506-03 Preferred 355 ml FDA listed
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69256-0503-05 Harris 355 ml FDA listed
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0286-12 CVS 355 ml FDA listed
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0355-26 CVS 769 ml FDA listed
Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0503-05 Retail 355 ml FDA listed
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0509-05 Retail 355 ml FDA listed
Kesin MAG-AL Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 81033-0006-01 Kesin 100 cups FDA listed
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0125-12 Chain 355 ml FDA listed
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 84415-0017-01 Everpharm 100 cups FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1317-83, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
23K
Units reimbursed last 4 qtrs
6.8M
Gross reimbursed last 4 qtrs
$212.1K
Avg / prescription
$9.24
Avg / unit
$0.0312
Latest quarter Q4 2025
5.2KRx
Medicaid pays / mL
$0.0312
gross reimbursed
vs
NADAC / mL
$0.0105
acquisition cost
=
Spread
+$0.0207
+197% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
50% FFS 50% MCO
Fee-for-service · 11,534 Rx Managed care · 11,419 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 23,837 units · 2,106 per 100k residents MT North Dakota: 7,854 units · 1,003 per 100k residents ND Minnesota: 368,356 units · 6,421 per 100k residents MN Wisconsin: 218,831 units · 3,703 per 100k residents WI Michigan: 753,100 units · 7,503 per 100k residents MI New York: 798,189 units · 4,078 per 100k residents NY Vermont: 18,840 units · 2,912 per 100k residents VT New Hampshire: 4,391 units · 313 per 100k residents NH Oregon: 334,285 units · 7,897 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 144,621 units · 1,152 per 100k residents IL Indiana: 351,005 units · 5,115 per 100k residents IN Ohio: 259,684 units · 2,204 per 100k residents OH Pennsylvania: 155,801 units · 1,202 per 100k residents PA New Jersey: 121,210 units · 1,305 per 100k residents NJ Massachusetts: 174,764 units · 2,496 per 100k residents MA California: 2,056,046 units · 5,277 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 21,055 units · 1,064 per 100k residents NE Missouri: no data reported MO Kentucky: 151,489 units · 3,347 per 100k residents KY West Virginia: 2,700 units · 153 per 100k residents WV Virginia: 68,696 units · 788 per 100k residents VA Maryland: 54,961 units · 889 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 77,118 units · 1,038 per 100k residents AZ New Mexico: no data reported NM Kansas: 3,600 units · 122 per 100k residents KS Arkansas: 4,070 units · 133 per 100k residents AR Tennessee: 3,354 units · 47.1 per 100k residents TN North Carolina: 32,323 units · 298 per 100k residents NC South Carolina: 28,355 units · 528 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 14,443 units · 316 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 4,865 units · 716 per 100k residents DC Hawaii: 18,629 units · 1,298 per 100k residents HI Texas: 521,542 units · 1,710 per 100k residents TX Florida: 1,032 units · 4.6 per 100k residents FL
Units reimbursed · per 100k residents
4.67,897
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oregon 7,897 /100k
2 Michigan 7,503 /100k
3 Minnesota 6,421 /100k
4 California 5,277 /100k
5 Indiana 5,115 /100k
6 New York 4,078 /100k
7 Wisconsin 3,703 /100k
8 Kentucky 3,347 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Aluminum hydroxide, magnesium hydroxide, dimethicone — the ingredient across all brands.

Top reported reactions

Burning Sensation1
Chest Pain1
Chromaturia1
Dizziness Postural1
Drug Interaction1
Dyspnoea1
Dysuria1

Reporter sex

6 reports
Male · 80%
Female · 20%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1317-83 You're viewing this 355 mL in 1 BOTTLE (0536-1317-83) 2020-08-01 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 13 words

Uses relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

⏱️ Dosage and Administration 64 words

Directions • shake well before each use • adults and children 12 years and older: take 10 mL to 20 mL (1-2 doses) four times a day or as directed by a doctor • do not exceed 80 mL (8 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor

⚠️ Warnings 65 words

Warnings 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 27 words

Other information • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg • store at room temperature • protect from freezing • keep tightly closed

🧪 Active Ingredient 22 words

Active ingredients (in each 10 mL dose) Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg

🧪 Inactive Ingredients 18 words

Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

🎯 Purpose 3 words

Purposes Antacid Antigas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.