SPL v1
SPL
SPL Set ID 634e8d52-6d04-42f9-98f6-2634473b5dfd
Route
ORAL
Published
Effective Date 2025-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (650 mg)
Inactive Ingredients
Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: SB6 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Sodium bicarbonate 10 gr (650 mg)

Uses

Relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5

TEMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL33162 U.S.A

Section 51945-4

Warnings
  • Do not takemore than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Directions
  • Do not use the maximum dosage for more than 2 weeks 
  • tablets may be swallowed whole or dissolved in water prior to use 
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours 
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Other Information
  • each tablet contains sodium 178 mg (7.74 mEq)
  • store at room temperature 15-30°C (59-86°F) in well-closed container as defined in the USP.
Inactive Ingredients

Microcrystalline cellulose, stearic acid.

Stop Use and Ask A Doctor If

symptoms last more than 2 weeks.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

Active Ingredient (in Each Tablet)

Sodium bicarbonate 10 gr (650 mg)

Ask A Doctor Before Use If You Have

a sodium restricted diet.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a presciption drug. Antacids may intract with certain prescription drugs.


Structured Label Content

Uses

Relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5 (42229-5)

TEMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL33162 U.S.A

Section 51945-4 (51945-4)

Purpose

Antacid

Warnings (WARNINGS)
  • Do not takemore than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Directions
  • Do not use the maximum dosage for more than 2 weeks 
  • tablets may be swallowed whole or dissolved in water prior to use 
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours 
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Other Information (Other information)
  • each tablet contains sodium 178 mg (7.74 mEq)
  • store at room temperature 15-30°C (59-86°F) in well-closed container as defined in the USP.
Inactive Ingredients (Inactive ingredients)

Microcrystalline cellulose, stearic acid.

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

symptoms last more than 2 weeks.

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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sodium bicarbonate 10 gr (650 mg)

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

a sodium restricted diet.

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

taking a presciption drug. Antacids may intract with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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