4624 - Major

4624 - Major
SPL v2
SPL
SPL Set ID ebf340c9-0b6d-13d2-e053-2995a90ae338
Route
ORAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (650 mg)
Inactive Ingredients
Croscarmellose Sodium Talc Microcrystalline Cellulose Stearic Acid Silicon Dioxide

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

Description

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

Uses

relieves:

 acid indigestion

 heartburn

 sour stomach

 upset stomach associated with these symptoms

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.

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 51727-6

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

Section 51945-4

NDC 0904-7261-61

MAJOR®

Unit Dose

Sodium Bicarbonate

Antacid

10 gr (650 mg)

100 Tablets

Section 53414-9

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

Section 55105-1

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

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

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.

Questions Or Comments?

(800) 616-2471


Structured Label Content

Uses

relieves:

 acid indigestion

 heartburn

 sour stomach

 upset stomach associated with these symptoms

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.

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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

NDC 0904-7261-61

MAJOR®

Unit Dose

Sodium Bicarbonate

Antacid

10 gr (650 mg)

100 Tablets

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

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.

Questions Or Comments? (Questions or comments?)

(800) 616-2471


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)