FDA.reportPublic FDA data

Pediacare Gas RELIEF DROPS

Manufacturer
Strides Pharma Inc | Denison Pharmaceuticals, LLC
Effective date
2017-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:54

Label at a glance#

ProductPediacare SIMETHICONE ANTIGAS
Active ingredientSILICON DIOXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves the symptoms of 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 determine dose; otherwise, use age. measure only with the enclosed syringe remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level. dispense liquid slowly into child's mouth, toward inner cheek may be mixed with 1 oz. of cool water, infant formula or other suitable liquids all dosages may be repeated ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 0.3 mL)

Simethicone 20 mg

(provided as simethicone emulsion 66.7 mg)

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find right dose on chart below. If possible, use weight to determine dose; otherwise, use age.
  • measure only with the enclosed syringe
  • remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level.
  • dispense liquid slowly into child's mouth, toward inner cheek
  • may be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • 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
  • clean syringe and replace cap tightly on bottle
  • mL = millilitre
      Age(yrs)   
weight(lbs)
 dose
infants
under 2
 under 24
 0.3mL
children 2
and over
 24 and over
 0.6mL

Other information

INFORMATION FOR PATIENTS SECTION

  • do not freeze
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , sucralose, xanthan gum

Questions

OTC - QUESTIONS SECTION

1-888-474-3099 

Monday – Friday 8 am to 5 pm

Eastern standard time.

PediaCare.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INFANTS 0-36 months

PediaCare® 

Gas Relief DROPS

SIMETHICONE-ANTIGAS

DYE-FREE Berry Flavor

1 FL OZ (30 mL)

Carton
Carton
Label
Label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59556-85359556-853-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
DIMETHICONE92RU3N3Y1OACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
abb03674-37fd-4dba-899f-2ab18c47ff514f7c878b-412d-4111-aa13-4c909bc1d4b42025-05-14WarningsExact identifier
spl set id: 4f7c878b-412d-4111-aa13-4c909bc1d4b4

Reported adverse events (FAERS/openFDA)#

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