All-family Mylanta

All-family Mylanta
SPL v1
SPL
SPL Set ID 19118884-2016-e86e-e063-6294a90a370c
Route
ORAL
Published
Effective Date 2024-05-17
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

Great-tasting

All-Family Mylanta ®

QUICKLY SOOTHES for fast relief

MULTI-SYMPTOM RELIEF

of heartburn, gas, and upset stomachs

due to overindulgence in food and drink

GREAT-TASTING mixed berry flavor

ACTIVE INGREDIENTS:

CALCIUM CARBONATE, SIMETHICONE

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

infirst +

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

2024 Infirst Healthcare Inc.

©Mylanta.com

Lot:

Exp:

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 use if 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

VALUE SIZE

ALL-FAMILY

Mylanta ®

ANTACID+ANTI-GAS

MULTI-SYMPTOM

STOMACH REMEDY

Fast Relief of Heartburn,

Gas, and Upset Stomachs

for Adults & Children

Ages 6+

MIXED BERRY FLAVOR

16 FL OZ (473 mL)

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)

Great-tasting

All-Family Mylanta ®

QUICKLY SOOTHES for fast relief

MULTI-SYMPTOM RELIEF

of heartburn, gas, and upset stomachs

due to overindulgence in food and drink

GREAT-TASTING mixed berry flavor

ACTIVE INGREDIENTS:

CALCIUM CARBONATE, SIMETHICONE

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

infirst +

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

2024 Infirst Healthcare Inc.

©Mylanta.com

Lot:

Exp:

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 use if 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)

VALUE SIZE

ALL-FAMILY

Mylanta ®

ANTACID+ANTI-GAS

MULTI-SYMPTOM

STOMACH REMEDY

Fast Relief of Heartburn,

Gas, and Upset Stomachs

for Adults & Children

Ages 6+

MIXED BERRY FLAVOR

16 FL OZ (473 mL)

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


Raw Label Data

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