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safeway acid reducer

Better Living Brands LLC Acid Reducer Drug Facts

Approved
Approval ID

5fd96bb9-bf1e-4acc-aa86-a303a3497612

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Safeway

DUNS: 009137209

Products 1

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

Lansoprazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-564
Application NumberANDA202319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (16)

LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/7/2025

Package/Label Principal Display Panel

Compare to Prevacid® 24 HR active ingredient

Signature Care®

Quality Guaranteed

24 Hour

Acid Reducer

LANSOPRAZOLE DELAYED-RELEASE CAPSULES 15 mg

Acid Reducer

Treats Frequent Heartburn

• May take 1 to 4 days for full effect

• Sodium Free

Actual Size

14 CAPSULES

One 14-Day Course of Treatment

acid_reducer_carton_image_1

acid_reducer_carton_image_2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/22/2021

Use

treats frequent heartburn (occurs**2 or more** days a week)

not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/22/2021

Active ingredient (in each capsule)

Lansoprazole 15 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/22/2021

Purpose

Acid Reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/7/2025

Warnings

Allergy alert:

do not use if you are allergic to lansoprazole

lansoprazole may cause severe skin reactions.
Symptoms may include:

skin reddening

blisters

rash
If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

**if you have:**

trouble or pain swallowing food, vomiting with blood, or bloody or black stools

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**
These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

liver disease

had heartburn over 3 months. This may be a sign of a more serious condition.

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

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

you need to take more than 1 course of treatment every 4 months

you get diarrhea

you develop a rash or joint pain

If pregnant or breast-feeding,

ask a health care 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: 3/22/2021

Directions

adults 18 years of age and older

this product is to be used once a day (every 24 hours), every day for 14 days

it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning

take every day for 14 days

do not take more than 1 capsule a day

swallow whole. Do not crush or chew capsules.

do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeat a 14-day course every 4 months

**do not take for more than 14 days or more often than every 4 months unless directed by a doctor**

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/3/2022

Other information

read the directions and warnings before use

keep the carton. It contains important information.

store at 20-25°C (68-77°F)

keep product out of high heat and humidity

protect product from moisture

close cap tightly after use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/22/2021

Inactive ingredients

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/18/2022

Questions or comments?

1-800-719-9260

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safeway acid reducer - FDA Drug Approval Details