careone extra strength gas relief cherry

SPL v2

SPL

SPL Set ID 1e8ed36d-5236-163b-e063-6294a90ad6ec

Route

oral

Published

Effective Date 2024-12-05

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

dimethicone (125 mg)

Inactive Ingredients

d&c red no. 30 aluminum lake magnesium stearate cellulose, microcrystalline sorbitol sucrose maltodextrin dextrose, unspecified form

Identifiers & Packaging

Pill Appearance

Imprint: G134 Shape: round Color: pink Size: 14 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-11-22

Purpose

Anti-gas

Description

Simethicone 125 mg

Medication Information

Warnings

Purpose

Anti-gas

Directions

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Other Information

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

Inactive Ingredients

D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.

Description

Simethicone 125 mg

Principal Display Panel

NDC 72476-134-73

CAREone^TM

Compare to the Active Ingredient in Gas-X^® Chewables Extra Strength*

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg- Anti-Gas

Cherry creme

FOR FAST RELIEF OF:

DISCOMFORT FROM GAS
BLOATING
PRESSURE

Actual Size

18 CHEWABLE TABLETS

Use(s)

relieves:

pressure
bloating
symptoms referred to as gas

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Active Ingredient(in Each Tablet)

Simethicone 125 mg

Structured Label Content

Warnings (WARNINGS)

Purpose (PURPOSE)

Anti-gas

Directions (DIRECTIONS)

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Other Information (OTHER INFORMATION)

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

Inactive Ingredients (INACTIVE INGREDIENTS)

D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 72476-134-73

CAREone^TM

Compare to the Active Ingredient in Gas-X^® Chewables Extra Strength*

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg- Anti-Gas

Cherry creme

FOR FAST RELIEF OF:

DISCOMFORT FROM GAS
BLOATING
PRESSURE

Actual Size

18 CHEWABLE TABLETS

Use(s) (USE(S))

relieves:

pressure
bloating
symptoms referred to as gas

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Center immediately.

Active Ingredient(in Each Tablet) (ACTIVE INGREDIENT(in each tablet))

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 30 ALUMINUM LAKE", "unii": "GE75M6YV5W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: pressure bloating symptoms referred to as gas", "PURPOSE": "Anti-gas", "WARNINGS": ".", "DIRECTIONS": "chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.", "OTHER INFORMATION": "do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)", "INACTIVE INGREDIENTS": "D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.", "PRINCIPAL DISPLAY PANEL": "NDC 72476-134-73 CAREone TM Compare to the Active Ingredient in Gas-X ® Chewables Extra Strength* EXTRA STRENGTH GAS RELIEF Simethicone 125 mg- Anti-Gas Cherry creme FOR FAST RELIEF OF: DISCOMFORT FROM GAS BLOATING PRESSURE Actual Size 18 CHEWABLE TABLETS", "KEEP OUT OF REACH OF CHILDREN.": "In case of overdose, get medical help or contact a Poison Control Center immediately.", "ACTIVE INGREDIENT(in each tablet)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.825524 · Updated: 2026-03-14T23:05:29.389553