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foster and thrive acid reducer

McKesson Acid Reducer Drug Facts

Approved
Approval ID

0c480ba4-b07e-4109-a9a9-5480b4a39a1d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 21, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

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

Famotidine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1101
Application NumberANDA077351
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2025
FDA Product Classification

INGREDIENTS (11)

FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/21/2025

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH PEPCID® AC ACTIVE INGREDIENT

Foster & Thrive™

MAXIMUM STRENGTH

Acid Reducer

Famotidine Tablets 20 mg

ACID REDUCER

Gluten Free

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

ACTUAL SIZE

50 TABLETS

foster&thrive-acid-reducer-carton- image.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/13/2023

Uses

relieves heartburn associated with acid indigestion and sour stomach

prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/13/2023

Active ingredient (in each tablet)

Famotidine 20 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/13/2023

Purpose

Acid reducer

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/21/2025

Directions

adults and children 12 years and over:

to**relieve**symptoms, swallow 1 tablet with a glass of water. Do not chew.

to**prevent**symptoms, swallow 1 tablet with a glass of water at any time from**10 to 60 minutes before**eating food or drinking beverages that cause heartburn

do not use more than 2 tablets in 24 hours

children under 12 years: ask a doctor

WARNINGS SECTION

LOINC: 34071-1Updated: 7/13/2023

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. 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)

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/31/2023

Other information

read the directions and warnings before use

keep the carton. It contains important information.

store at 20°-25°C (68°-77°F)

protect from moisture

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/13/2023

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/21/2025

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