SPL v1
SPL
SPL Set ID 0f867f56-4bc0-4a85-b9d2-a16282b7c82b
Route
ORAL
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (650 mg)
Inactive Ingredients
Stearic Acid Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: SB6 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Drug Facts

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Drug Facts

Uses

relieves

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

Drug Facts

Section 50570-1

Do not take more 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 15-30ºC (59-86°F)
Inactive Ingredients

Microcrystalline cellulose, stearic acid

Questions Or Comments?

Call toll free 1-844-912-4012

Stop Use and Ask A Doctor If

symptoms last more than 2 weeks.

Keep Out of Reach of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 prescription drug. Antacids may interact with certain prescription drugs.

Principal Display Panel 1000 Tablets Bottle Label


Structured Label Content

Uses

relieves

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

Drug Facts

Section 50570-1 (50570-1)

Do not take more 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. 

Purpose

Antacid

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 15-30ºC (59-86°F)
Inactive Ingredients (Inactive ingredients)

Microcrystalline cellulose, stearic acid

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-912-4012

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

symptoms last more than 2 weeks.

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.

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

ask a health professional before use.

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 taking a prescription drug. Antacids may interact with certain prescription drugs.

Principal Display Panel 1000 Tablets Bottle Label (PRINCIPAL DISPLAY PANEL - 1000 Tablets Bottle Label)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)