Publix Super Markets, Inc. Dual Action Complete Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Famotidine (10 mg) Calcium Cation (800 mg) Hydroxide Ion (165 mg)

Inactive Ingredients

Anhydrous Lactose Aspartame D&c Red No. 7 Dextrates Fd&c Blue No. 1 Fd&c Red No. 40 Glyceryl Monostearate Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polysorbate 80 Povidone, Unspecified Talc

Identifiers & Packaging

Pill Appearance

Imprint: L321 Shape: round Color: pink Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2018-11-06

Medication Information

Purpose

Acid reducer Antacid

Description

Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Use

relieves heartburn associated with acid indigestion and sour stomach

Purposes

Acid reducer

Antacid

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Directions

•
adults and children 12 years and over:
•
do not swallow tablet whole: chew completely
•
to relieve symptoms, chew 1 tablet before swallowing
•
do not use more than 2 chewable tablets in 24 hours
•
children under 12 years: ask a doctor

Do Not Use

•
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
•
with other acid reducers

Other Information

•
each tablet contains: calcium 330 mg; magnesium 80 mg
•
Phenylketonurics: Contains Phenylalanine 2 mg per tablet
•
read the directions and warnings before use
•
read the bottle. It contains important information.
•
store at 68-77^°F (20-25^°C)
•
protect from moisture

Inactive Ingredients

anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Stop Use and Ask A Doctor If

•
your heartburn continues or worsens
•
you need to take this product for more than 14 days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have

•
had heartburn over 3 months. This may be a sign of a more serious condition.
•
heartburn with lightheadedness, sweating, or dizziness
•
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
•
frequent chest pain
•
frequent wheezing, particularly with heartburn
•
unexplained weight loss
•
nausea or vomiting
•
stomach pain
•
kidney disease

Package/label Principal Display Panel

P

BERRY FLAVOR

dual action complete

FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

ACID REDUCER + ANTACID

Just one tablet relieves heartburn due to acid indigestion.

ACTUAL SIZE

Compare to active ingredients in Pepcid Complete^®.

25 CHEWABLE TABLETS

Active Ingredients (in Each Chewable Tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Structured Label Content

Use

relieves heartburn associated with acid indigestion and sour stomach

Purposes

Acid reducer

Antacid

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Directions

•
adults and children 12 years and over:
•
do not swallow tablet whole: chew completely
•
to relieve symptoms, chew 1 tablet before swallowing
•
do not use more than 2 chewable tablets in 24 hours
•
children under 12 years: ask a doctor

Do Not Use (Do not use)

•
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
•
with other acid reducers

Other Information (Other information)

•
each tablet contains: calcium 330 mg; magnesium 80 mg
•
Phenylketonurics: Contains Phenylalanine 2 mg per tablet
•
read the directions and warnings before use
•
read the bottle. It contains important information.
•
store at 68-77^°F (20-25^°C)
•
protect from moisture

Inactive Ingredients (Inactive ingredients)

anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•
your heartburn continues or worsens
•
you need to take this product for more than 14 days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
had heartburn over 3 months. This may be a sign of a more serious condition.
•
heartburn with lightheadedness, sweating, or dizziness
•
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
•
frequent chest pain
•
frequent wheezing, particularly with heartburn
•
unexplained weight loss
•
nausea or vomiting
•
stomach pain
•
kidney disease

Package/label Principal Display Panel (Package/Label Principal Display Panel)

P

BERRY FLAVOR

dual action complete

FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

ACID REDUCER + ANTACID

Just one tablet relieves heartburn due to acid indigestion.

ACTUAL SIZE

Compare to active ingredients in Pepcid Complete^®.

25 CHEWABLE TABLETS

Active Ingredients (in Each Chewable Tablet) (Active ingredients (in each chewable tablet))

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "FAMOTIDINE", "unii": "5QZO15J2Z8", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "800", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "165", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 7", "unii": "ECW0LZ41X8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRATES", "unii": "G263MI44RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "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": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves heartburn associated with acid indigestion and sour stomach", "Purposes": "Acid reducer Antacid", "Warnings": "Allergy alert : Do not use if you are allergic to famotidine or other acid reducers", "Directions": "• adults and children 12 years and over: • do not swallow tablet whole: chew completely • to relieve symptoms, chew 1 tablet before swallowing • do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor", "Do not use": "• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. • with other acid reducers", "Other information": "• each tablet contains: calcium 330 mg; magnesium 80 mg • Phenylketonurics: Contains Phenylalanine 2 mg per tablet • read the directions and warnings before use • read the bottle. It contains important information. • store at 68-77 ° F (20-25 ° C) • protect from moisture", "Inactive ingredients": "anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc", "Stop use and ask a doctor if": "• your heartburn continues or worsens • you need to take this product for more than 14 days", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Ask a doctor before use if you have": "• had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with lightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • kidney disease", "Package/Label Principal Display Panel": "P BERRY FLAVOR dual action complete FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE) ACID REDUCER + ANTACID Just one tablet relieves heartburn due to acid indigestion. ACTUAL SIZE Compare to active ingredients in Pepcid Complete ® . 25 CHEWABLE TABLETS", "Active ingredients (in each chewable tablet)": "Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs."}

Publix Super Markets, Inc. Dual Action Complete Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information