Rugby Infant Drops

Rugby Infant Drops
SPL v1
SPL
SPL Set ID b7f8335c-f853-4098-8960-e6c892f8ab0d
Route
ORAL
Published
Effective Date 2020-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Anhydrous Citric Acid Maltitol Cellulose, Microcrystalline Water Sodium Benzoate Sodium Citrate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-12-01
Description

Simethicone 20 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Use

relieves the symptoms referred to as gas

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Warnings



Directions
  • shake well before using
  • 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
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
  • may be mixed with 1 oz of water, infant formula or other suitable liquid
  • for best results, clean dropper after each use and replace original cap
Age (years) Weight (lbs) Dose
infants (under 2)

under 24

0.3 mL

children (over 2)

over 24

0.6 mL

Package Label

Other Information
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing
Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions Or Comments?

1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Structured Label Content

Use

relieves the symptoms referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Purpose

Antigas

Warnings



Directions
  • shake well before using
  • 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
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
  • may be mixed with 1 oz of water, infant formula or other suitable liquid
  • for best results, clean dropper after each use and replace original cap
Age (years) Weight (lbs) Dose
infants (under 2)

under 24

0.3 mL

children (over 2)

over 24

0.6 mL

Package Label (package Label)

Other Information (Other information)
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions Or Comments? (Questions or comments?)

1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone 20 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.204964 · Updated: 2026-03-14T22:58:05.187766