0f867f56-4bc0-4a85-b9d2-a16282b7c82b

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

Purpose

Antacid

Description

Drug Facts


Medication Information

Active Ingredient

Sodium Bicarbonate 10 gr (650 mg)

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
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
  • each tablet contains:sodium 178 mg (7.74 meq)
  • store at room temperature 15-30ºC (59-86°F)
Inactive Ingredients

Microcrystalline cellulose, stearic acid

Description

Drug Facts

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. 

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.

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

Active Ingredient (Active ingredient (in each tablet))

Sodium Bicarbonate 10 gr (650 mg)

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
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

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. 

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.

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

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