Quality Choice Infants Dye Free Gas Relief Drops

Drug Facts

Composition & Product

Active Ingredients

Dimethicone, Unspecified (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 2018-12-17

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. 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 (toward 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

Principal Display Panel

NDC# 63868-696-30

QUALITY CHOICE ^®

*Compare to the Active Ingredient in Infants’ Mylicon ^®

Infants’ Dye-Free Gas Relief Drops

Relieves Gas Symptoms

Simethicone Antigas 20 mg

No Saccharin

No Artificial Colors

No Artificial Flavor

Non-Staining

1 Fl. OZ (30ml)

100 Doses

100% QC SATISFACTION GUARANTEED

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

Questions Or Comments ?

Call 1-866-467-2748

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. 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 (toward 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

Principal Display Panel

NDC# 63868-696-30

QUALITY CHOICE ^®

*Compare to the Active Ingredient in Infants’ Mylicon ^®

Infants’ Dye-Free Gas Relief Drops

Relieves Gas Symptoms

Simethicone Antigas 20 mg

No Saccharin

No Artificial Colors

No Artificial Flavor

Non-Staining

1 Fl. OZ (30ml)

100 Doses

100% QC SATISFACTION GUARANTEED

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

Questions Or Comments ? (Questions or comments ?)

Call 1-866-467-2748

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

Simethicone 20 mg

Advanced Ingredient Data

[{"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": ""}, {"name": "DIMETHICONE, UNSPECIFIED", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "0.3", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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 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 (toward 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", "Principal Display Panel": "NDC# 63868-696-30 QUALITY CHOICE ® *Compare to the Active Ingredient in Infants’ Mylicon ® Infants’ Dye-Free Gas Relief Drops Relieves Gas Symptoms Simethicone Antigas 20 mg No Saccharin No Artificial Colors No Artificial Flavor Non-Staining 1 Fl. OZ (30ml) 100 Doses 100% QC SATISFACTION GUARANTEED Distributed by: C.D.M.A. Inc. © 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON ® Drops.", "Questions or comments ?": "Call 1-866-467-2748", "Active ingredient (in each 0.3 mL)": "Simethicone 20 mg"}

Quality Choice Infants Dye Free Gas Relief Drops

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information