family wellness infants gas relief

Manufacturer
Family Dollar Services Inc
Effective date
2019-09-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:42

Label at a glance#

Productfamily wellness infants gas relief
Active ingredientDIMETHICONE
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 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. If you pass the prescribed level, simply push syringe back until you...

Storage and handling

• do not use if printed bottle wrap is broken or missing • store at 20-25°C (68-77°F) • do not freeze

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

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

do not exceed 12 doses per day

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 right away (1-800-222-1222).

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. If you pass the prescribed level, simply push syringe back until you have reached the desired 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

  • do not use if printed bottle wrap is broken or missing
  • store at 20-25°C (68-77°F)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN INFANTS’ MYLICON®

Infants’ GAS RELIEF

Simethicone 20 mg - Antigas

DYE FREE DROPS

Non-Staining

Gently breaks down baby’s gas bubbles

Safe enough to use at every feeding**

#1 Pediatrician Recommended Active Ingredient

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

**use as directed

1 FL OZ (30 mL)

infants gas relief image
infants gas relief image

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-88255319-882-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

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
81202039-80dc-4778-8cae-5437dbfb521422245c00-528f-42d0-860e-a9ceecfe36902022-11-04WarningsExact identifier
spl set id: 22245c00-528f-42d0-860e-a9ceecfe3690

Reported adverse events (FAERS/openFDA)#

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