Rugby ®

Rugby ®
SPL v2
SPL
SPL Set ID 27fce442-e328-41d2-bab9-87ab21550c04
Route
ORAL
Published
Effective Date 2021-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Anhydrous Citric Acid Microcrystalline Cellulose Polysorbate 60 Potassium Sorbate Water Sodium Benzoate Sorbitan Monostearate Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-01

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Uses

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

Directions
  • 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
  • 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

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

Questions Or Comments?

1-800-645-2158

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

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg


Structured Label Content

Uses

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

Purpose

Antigas

Directions
  • 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 (Other information)
  • 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-645-2158

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

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)