Heartland Pharma 44-608

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Starch, Corn Sucralose Tribasic Calcium Phosphate Dimethicone 410

Identifiers & Packaging

Pill Appearance

Imprint: 44;608 Shape: round Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-30

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Directions

do not take more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Other Information

each tablet contains: calcium 85 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
use by expiration date on package

Inactive Ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions Or Comments?

1-800-383-0648

Principal Display Panel

Heartland®

Pharma Co.

NDC 80136-859-68

Extra Strength

GAS RELIEF

Simethicone 125 mg Chewable Tablets

Antigas

Relieves

Pressure

Bloating

Discomfort

Compare to the

active ingredient in

Gas-X® Extra Strength*

Chew or crush tablets completely before swallowing.

100 Chewable Tablets

Actual

Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark

Gas-X® Extra Strength.

50844 REV1220A60812

Distributed by:

NORTHEAST PHARMA

Williston, VT 05495

www.heartlandpharmaco.com

1-800-383-0648

44-608

Active Ingredient (in Each Chewable Tablet)

Simethicone 125 mg

Structured Label Content

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Purpose

Antigas

Directions

do not take more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Other Information (Other information)

each tablet contains: calcium 85 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions Or Comments? (Questions or comments?)

1-800-383-0648

Principal Display Panel (Principal display panel)

Heartland®

Pharma Co.

NDC 80136-859-68

Extra Strength

GAS RELIEF

Simethicone 125 mg Chewable Tablets

Antigas

Relieves

Pressure

Bloating

Discomfort

Compare to the

active ingredient in

Gas-X® Extra Strength*

Chew or crush tablets completely before swallowing.

100 Chewable Tablets

Actual

Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark

Gas-X® Extra Strength.

50844 REV1220A60812

Distributed by:

NORTHEAST PHARMA

Williston, VT 05495

www.heartlandpharmaco.com

1-800-383-0648

44-608

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30 ALUMINUM LAKE", "unii": "GE75M6YV5W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40 ALUMINUM LAKE", "unii": "6T47AS764T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE 410", "unii": "TYU5GP6XGE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of pressure, bloating, and fullness commonly referred to as gas", "Purpose": "Antigas", "Directions": "do not take more than directed chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime do not exceed 4 chewable tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor", "Other information": "each tablet contains: calcium 85 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture use by expiration date on package", "Inactive ingredients": "crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate", "Questions or comments?": "1-800-383-0648", "Principal display panel": "Heartland® Pharma Co. NDC 80136-859-68 Extra Strength GAS RELIEF Simethicone 125 mg Chewable Tablets Antigas Relieves Pressure Bloating Discomfort Compare to the active ingredient in Gas-X® Extra Strength* Chew or crush tablets completely before swallowing. 100 Chewable Tablets Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark Gas-X® Extra Strength. 50844 REV1220A60812 Distributed by: NORTHEAST PHARMA Williston, VT 05495 www.heartlandpharmaco.com 1-800-383-0648 44-608", "Active ingredient (in each chewable tablet)": "Simethicone 125 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information