sodium bicarbonate

sodium bicarbonate
SPL v4
SPL
SPL Set ID 60c2a176-8854-4479-b853-d07fe9a1830c
Route
oral
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sodium cation (650 mg)
Inactive Ingredients
croscarmellose sodium microcrystalline cellulose silicon dioxide stearic acid talc

Identifiers & Packaging

Pill Appearance
Imprint: CPC;77 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-10-26

Description

Active ingredient (in each tablet) Sodium bicarbonate 10 gr (650 mg)


Medication Information

Warnings and Precautions

Warnings

Uses

relieves:

 acid indigestion

 heartburn

 sour stomach

 upset stomach associated with these symptoms

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

 store in a dry place at 15° – 30°C (59° – 86°F)  Retain this carton for

important information.

Inactive Ingredients

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc

Description

Active ingredient (in each tablet) Sodium bicarbonate 10 gr (650 mg)

Principal Display Panel

NDC 55154-4324-0

SODIUM BICARBONATE

10 gr (650 mg)

ANTACID

10 TABLETS

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5

Unit Dose

Sodium Bicarbonate

DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

WARNING: This product can expose you to chemicals including

lead, which is known to the State of California to cause cancer

and birth defects or other reproductive harm. For more information

go to www.P65Warnings.ca.gov.

Overbagged with 10 tablets per bag, NDC 55154-4324-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58544760224

Rev. 05/22

M-29

Re-order No. 701316

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms last more than 2 weeks.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you have a sodium restricted diet.

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 the maximum dosage

for more than 2 weeks, except under the advice and supervision of a physician.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antacid

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Questions Or Comments?

(800) 616-2471


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses

relieves:

 acid indigestion

 heartburn

 sour stomach

 upset stomach associated with these symptoms

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

 store in a dry place at 15° – 30°C (59° – 86°F)  Retain this carton for

important information.

Inactive Ingredients

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc

Principal Display Panel

NDC 55154-4324-0

SODIUM BICARBONATE

10 gr (650 mg)

ANTACID

10 TABLETS

Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5 (42229-5)

Unit Dose

Sodium Bicarbonate

DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

WARNING: This product can expose you to chemicals including

lead, which is known to the State of California to cause cancer

and birth defects or other reproductive harm. For more information

go to www.P65Warnings.ca.gov.

Overbagged with 10 tablets per bag, NDC 55154-4324-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58544760224

Rev. 05/22

M-29

Re-order No. 701316

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms last more than 2 weeks.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a sodium restricted diet.

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 the maximum dosage

for more than 2 weeks, except under the advice and supervision of a physician.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antacid

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Questions Or Comments? (Questions or comments?)

(800) 616-2471


Advanced Ingredient Data


Raw Label Data

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