Premier Value Infants' Drops Gas Relief Drug Facts

SPL v8

SPL

SPL Set ID 7b887e53-a70a-4f33-9472-e1175b24400a

Route

ORAL

Published

Effective Date 2024-10-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (20 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium, Unspecified 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 2015-01-09

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
▪
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 the inner cheek
▪
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
▪
clean dropper after each use - replace bottle with original cap

age (yr)	weight (lb)	dose
infants under 2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other Information

▪
tamper evident: do not use if printed seal under cap is torn or missing
▪
store at room temperature
▪
do not freeze
▪
see bottom panel for lot 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

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS*

Premier Value^®

Infants'

Gas Relief

Non-Staining formula

Simethicone 20 mg/Antigas

•
Dye Free
•
No Saccharin
•
No Artificial Colors
•
No Artificial flavors

Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose)

1 Fl. OZ (30ml)

100 Doses

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon^® Drops.

Premier Value Infants' Gas Relief

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
▪
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 the inner cheek
▪
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
▪
clean dropper after each use - replace bottle with original cap

age (yr)	weight (lb)	dose
infants under 2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other Information (Other information)

▪
tamper evident: do not use if printed seal under cap is torn or missing
▪
store at room temperature
▪
do not freeze
▪
see bottom panel for lot 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

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS*

Premier Value^®

Infants'

Gas Relief

Non-Staining formula

Simethicone 20 mg/Antigas

•
Dye Free
•
No Saccharin
•
No Artificial Colors
•
No Artificial flavors

Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose)

1 Fl. OZ (30ml)

100 Doses

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon^® Drops.

Premier Value Infants' Gas Relief

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

Simethicone 20 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "0.3", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOSTEARATE", "unii": "NVZ4I0H58X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods", "Purpose": "Antigas", "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 the inner cheek ▪ dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids ▪ clean dropper after each use - replace bottle with original cap age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL", "Other information": "▪ tamper evident: do not use if printed seal under cap is torn or missing ▪ store at room temperature ▪ do not freeze ▪ see bottom panel for lot 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", "Principal Display Panel": "COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS* Premier Value ® Infants' Gas Relief Non-Staining formula Simethicone 20 mg/Antigas • Dye Free • No Saccharin • No Artificial Colors • No Artificial flavors Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose) 1 Fl. OZ (30ml) 100 Doses Distributed by Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ® Drops. Premier Value Infants' Gas Relief", "Active ingredient (in each 0.3 mL)": "Simethicone 20 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:05.744355 · Updated: 2026-03-14T23:04:35.063520