FDA.reportPublic FDA data

Rugby ® Infants’ Gas Relief Simethicone Drops

Manufacturer
ATLANTIC BIOLOGICALS CORP. | Unit Dose Solutions
Effective date
2025-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:40

Label at a glance#

ProductInfants
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Dosage and administration

shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle. pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly d...

Storage and handling

tamper evident: do not use if printed seal under cap is broken or missing Store at room temperature do not freeze see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Warnings

WARNINGS SECTION

Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle.
  • pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
  • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
  • do not exceed 12 doses per day.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids.
  • Replace cap tightly to maintain child resistance
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

STORAGE AND HANDLING SECTION

  • tamper evident: do not use if printed seal under cap is broken or missing
  • Store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Infants’

Simethicone Drops

Antigas

•Dye-free•Non-staining formula•No Saccharin•No Artificial Color•No Artificial Flavor

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN2
198857simethicone 66.7 MG/ML Oral SuspensionSCD2
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY2
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1303-12025-04-25C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-22025-04-25C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-32025-04-25C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-42025-04-25C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-52025-04-25C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-12023-01-30C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-22023-01-30C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-32023-01-30C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-42023-01-30C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops
17856-1303-52023-01-30C16284748780-1f386c64a-06d3-0266-e053-dadaa90a7c1aRugby ® Infants’ Gas Relief Simethicone Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1303-1Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-1Infants0.3 mL in 1 SYRINGESUSPENSION/ DROPS0.32
17856-1303-2Infants0.3 mL in 1 SYRINGESUSPENSION/ DROPS0.32
17856-1303-2Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-3Infants0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.62
17856-1303-3Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-4Infants120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1202
17856-1303-4Infants0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.62
17856-1303-5Infants1.2 mL in 1 SYRINGESUSPENSION/ DROPS1.22
17856-1303-5Infants60 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1303INFANTS (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 10 package rows20250426_27fce442-e328-41d2-bab9-87ab21550c04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1303-1EA - Each17856-1303b8601f9f-9eb1-4837-a529-b4cf80be384a12025-12-16
17856-1303-2EA - Each17856-1303786ecd51-d680-46a0-bbb9-cd4ef81721b912022-02-07
0536-1303-75ML - Milliliter0536-1303bd38d3eb-43ff-410b-af74-656cef6baf9912021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-130317856-1303-1, 17856-1303-2, 17856-1303-3, 17856-1303-4, 17856-1303-5
0536-1303

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
ndc (product): 0536-1303
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
ndc (package): 17856-1303-4
ndc (package): 17856-1303-2
ndc (package): 17856-1303-5
ndc (package): 17856-1303-3
ndc (package): 17856-1303-1
ndc (product): 17856-1303
ndc11 (package): 17856130304
ndc11 (package): 17856130302
ndc11 (package): 17856130303
ndc11 (package): 17856130305
ndc11 (package): 17856130301
spl id: 3288018d-5d72-4792-e063-6294a90a2c8c
spl set id: 27fce442-e328-41d2-bab9-87ab21550c04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.