Xiamen-aafes Soft Chews

SPL v1

SPL

SPL Set ID 3de81025-b81c-374a-e063-6394a90a00cf

Route

ORAL

Published

Effective Date 2025-07-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (1177 mg)

Inactive Ingredients

Glycerin Sucralose Gelatin Sucrose Lecithin, Soybean Skim Milk Fd&c Red No. 40 Maltose Syrup Palm Oil C14-18 Mono-and Di-glycerides

Identifiers & Packaging

Pill Appearance

Shape: rectangle Color: red Size: 24 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-03

Description

Active ingredient (in each chew) Calcium carbonate 1,177 mg

Medication Information

Warnings and Precautions

Warnings

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain perscription drugs.

Indications and Usage

Uses

Relieves

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Dosage and Administration

Directions

Adults and children 12 years of age and over: chew 2-3 chews, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow chews whole.
Do not take for symptoms that persist for mare than 2 weekis unless advised by a doctor

Description

Active ingredient (in each chew) Calcium carbonate 1,177 mg

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

do not take more than 6 chews in 24 hours
do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
if pregnant do not take more than 4 chews in 24 hours

Section 51727-6

Inactive ingredients:

FD&C Red No. 40, Flaors, Gelatin, Glycerin, Soy Lecithin, Maltose Syrup, Mono and Di-glycerides of Fatty Acids, Nonfat dry milk, Palm Oil, Sucralose, Sucrose Fatty Acid Esters.

Section 51945-4

Section 53413-1

Questions or comments? (866) 306-9136

You may also report serious side effects to this phone number.

Mon-Fri 9:00 a.m - 5:00 p.m ET

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each chew)

Calcium carbonate 1,177 mg

Section 60561-8

Other information

Each chew contains:calcium 470 mg
Store at room temperatrue 20-25ºC (68-77ºF). Keep bag tightly closed.
Do not use if packaging is torn or damaged.
Contains: soy

Structured Label Content

Indications and Usage (34067-9)

Uses

Relieves

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over: chew 2-3 chews, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow chews whole.
Do not take for symptoms that persist for mare than 2 weekis unless advised by a doctor

Warnings and Precautions (34071-1)

Warnings

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain perscription drugs.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

do not take more than 6 chews in 24 hours
do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
if pregnant do not take more than 4 chews in 24 hours

Section 51727-6 (51727-6)

Inactive ingredients:

FD&C Red No. 40, Flaors, Gelatin, Glycerin, Soy Lecithin, Maltose Syrup, Mono and Di-glycerides of Fatty Acids, Nonfat dry milk, Palm Oil, Sucralose, Sucrose Fatty Acid Esters.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? (866) 306-9136

You may also report serious side effects to this phone number.

Mon-Fri 9:00 a.m - 5:00 p.m ET

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each chew)

Calcium carbonate 1,177 mg

Section 60561-8 (60561-8)

Other information

Each chew contains:calcium 470 mg
Store at room temperatrue 20-25ºC (68-77ºF). Keep bag tightly closed.
Do not use if packaging is torn or damaged.
Contains: soy

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SKIM MILK", "unii": "6A001Y4M5A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTOSE SYRUP", "unii": "00JKR0NZ8O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALM OIL", "unii": "5QUO05548Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C14-18 MONO-AND DI-GLYCERIDES", "unii": "82TZ9D9546", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "1177", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms", "34068-7": "Directions Adults and children 12 years of age and over: chew 2-3 chews, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow chews whole. Do not take for symptoms that persist for mare than 2 weekis unless advised by a doctor", "34071-1": "Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain perscription drugs.", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not take more than 6 chews in 24 hours do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor if pregnant do not take more than 4 chews in 24 hours", "51727-6": "Inactive ingredients: FD&C Red No. 40, Flaors, Gelatin, Glycerin, Soy Lecithin, Maltose Syrup, Mono and Di-glycerides of Fatty Acids, Nonfat dry milk, Palm Oil, Sucralose, Sucrose Fatty Acid Esters.", "53413-1": "Questions or comments? (866) 306-9136 You may also report serious side effects to this phone number. Mon-Fri 9:00 a.m - 5:00 p.m ET", "53414-9": "If pregnant or breast-feeding , ask a health professional before use", "55105-1": "Purpose Antacid", "55106-9": "Active ingredient (in each chew) Calcium carbonate 1,177 mg", "60561-8": "Other information Each chew contains: calcium 470 mg Store at room temperatrue 20-25ºC (68-77ºF). Keep bag tightly closed. Do not use if packaging is torn or damaged. Contains: soy"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.470649 · Updated: 2026-03-14T23:09:59.416921