All-family Mylanta

SPL v1

SPL

SPL Set ID a70f113d-d5a3-44f5-b223-cd1b0e159e1a

Route

ORAL

Published

Effective Date 2025-11-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (800 mg) Dimethicone (80 mg)

Inactive Ingredients

Benzyl Alcohol Xanthan Gum Sodium Carbonate Carboxymethylcellulose Calcium D&c Red No. 28 Microcrystalline Cellulose Water Sorbitol Glycerin Sucralose

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-21

Description

Active ingredients (in each 10 mL dose) Calcium carbonate 800 mg Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses relieves:

• heartburn • acid indigestion • sour stomach

• upset stomach due to thse symptoms

• pressure and bloating commonly referred to as gas

• overindulgence in food and drink

Dosage and Administration

Directions

• shake well before use • measure with dosing cup provided

• take as needed, between meals, at bedtime or as directed by a doctor

• do not use the maximum dosage for more than 2 weeks

• follow directions based on age below

Age	Dosage
children ages 6-11 yrs	10 mL. Not to exceed more than 30 mL in 24 hours
adults and children 12 yrs of age and over	10-20 mL. Not to exceed more than 60 mL in 24 hours

• mL=milliliter

Description

Active ingredients (in each 10 mL dose) Calcium carbonate 800 mg Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

Section 42229-5

Distributed by:

Sportpharm

2237 N Commerce Parkway,

STE 1, Weston, Florida-33326

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

Section 50568-5

Ask a doctor or pharmacist before useif you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? call 1-844-695-6624

toll free (English and Spanish)

Section 55105-1

Purposes

Antacid

Anti-gas

Section 55106-9

Active ingredients

(in each 10 mL dose)

Calcium carbonate 800 mg

Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

Other Information

• each 10 mL dose contains:

calcium 320 mg; sodium 5 mg

• store between 20-25°C (68-77°F), do not freeze

Structured Label Content

Indications and Usage (34067-9)

Uses relieves:

• heartburn • acid indigestion • sour stomach

• upset stomach due to thse symptoms

• pressure and bloating commonly referred to as gas

• overindulgence in food and drink

Dosage and Administration (34068-7)

Directions

• shake well before use • measure with dosing cup provided

• take as needed, between meals, at bedtime or as directed by a doctor

• do not use the maximum dosage for more than 2 weeks

• follow directions based on age below

Age	Dosage
children ages 6-11 yrs	10 mL. Not to exceed more than 30 mL in 24 hours
adults and children 12 yrs of age and over	10-20 mL. Not to exceed more than 60 mL in 24 hours

• mL=milliliter

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Distributed by:

Sportpharm

2237 N Commerce Parkway,

STE 1, Weston, Florida-33326

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before useif you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? call 1-844-695-6624

toll free (English and Spanish)

Section 55105-1 (55105-1)

Purposes

Antacid

Anti-gas

Section 55106-9 (55106-9)

Active ingredients

(in each 10 mL dose)

Calcium carbonate 800 mg

Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

Other Information (Other information)

• each 10 mL dose contains:

calcium 320 mg; sodium 5 mg

• store between 20-25°C (68-77°F), do not freeze

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CARBONATE", "unii": "45P3261C7T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE CALCIUM", "unii": "UTY7PDF93L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "800", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves: • heartburn • acid indigestion • sour stomach • upset stomach due to thse symptoms • pressure and bloating commonly referred to as gas • overindulgence in food and drink", "34068-7": "Directions • shake well before use • measure with dosing cup provided • take as needed, between meals, at bedtime or as directed by a doctor • do not use the maximum dosage for more than 2 weeks • follow directions based on age below Age Dosage children ages 6-11 yrs 10 mL. Not to exceed more than 30 mL in 24 hours adults and children 12 yrs of age and over 10-20 mL. Not to exceed more than 60 mL in 24 hours • mL=milliliter", "34071-1": "Warnings", "42229-5": "Distributed by: Sportpharm 2237 N Commerce Parkway, STE 1, Weston, Florida-33326 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.", "51727-6": "Inactive ingredients benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum", "53413-1": "Questions or comments? call 1-844-695-6624 toll free (English and Spanish)", "55105-1": "Purposes Antacid Anti-gas", "55106-9": "Active ingredients (in each 10 mL dose) Calcium carbonate 800 mg Simethicone Emulsion 266.6 mg/ Simethicone 80 mg", "Other information": "• each 10 mL dose contains: calcium 320 mg; sodium 5 mg • store between 20-25°C (68-77°F), do not freeze"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:56.673845 · Updated: 2026-03-14T23:13:25.872506