MedPath

Dual Action Complete

HEB Dual Action Complete Drug Facts

Approved
Approval ID

ea712fc4-7f27-4556-b1b8-028f3f6ce57a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

H E B

DUNS: 007924756

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Famotidine, Calcium Carbonate, Magnesium Hydroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37808-121
Application NumberANDA077355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (15)

FAMOTIDINEActive
Quantity: 10 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 800 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 165 mg in 1 1
Code: NBZ3QY004S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

Principal Display Panel

Compare to Pepcid Complete® active ingredients

H-E-B®

Dual Action Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets (Chewable)

Cool Mint Flavor

Acid Reducer + Antacid

Just One Tablet!

Relieves Heartburn Due to Acid indigestion

25 CHEWABLE TABLETS

actual size

![heb-dual-action-complete-container-image.jpg](/dailymed/image.cfm?name=heb- dual-action-complete-container-image.jpg&id=885514)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/7/2016

Use

relieves heartburn associated with acid indigestion and sour stomach

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/7/2016

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/27/2018

Purposes

Acid reducer

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 4/23/2020

Warnings

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

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

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

Ask a doctor or pharmacist before use if you are

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

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)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/27/2018

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/23/2020

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 20-25°C (68-77°F) 

protect from moisture

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/7/2016

Inactive ingredients

anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/27/2018

Questions or comments?

1-800-719-9260

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Dual Action Complete - FDA Drug Approval Details