Sodium Bicarbonate 10 Gr Tablets, Usp

Drug Facts

Composition & Product

Active Ingredients

Bicarbonate Ion (650 mg)

Inactive Ingredients

Croscarmellose Sodium Microcrystalline Cellulose Silicon Dioxide Stearic Acid Talc

Identifiers & Packaging

Pill Appearance

Imprint: 294;R Shape: round Color: white Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-02-01

Medication Information

Warnings and Precautions

Warnings

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.

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.

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

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

Indications and Usage

Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

Dosage and Administration

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

How Supplied

Product: 50090-3021

NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE

Description

Drug Facts Active ingredients (in each tablet) Sodium Bicarbonate 10 gr (650mg)

Section 42229-5

11790-11-16 REV 11/16

Manufactured for: Manufactured by:

Rising Pharmaceuticals, Inc. Contract Pharmacal Corp.

Allendale, NJ 07401 Hauppauge, NY 11788

Lot No.:

Exp. Date:

Section 44425-7

Other Information: Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive Ingredients: Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.

Section 53413-1

Questions? 1-866-562-4597

Section 55105-1

Purpose

Antacid

Section 55106-9

Drug Facts

Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

Sodium Bicarbonate

Structured Label Content

Indications and Usage (34067-9)

Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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.

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.

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

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

Section 42229-5 (42229-5)

11790-11-16 REV 11/16

Manufactured for: Manufactured by:

Rising Pharmaceuticals, Inc. Contract Pharmacal Corp.

Allendale, NJ 07401 Hauppauge, NY 11788

Lot No.:

Exp. Date:

Section 44425-7 (44425-7)

Other Information: Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive Ingredients: Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.

Section 53413-1 (53413-1)

Questions? 1-866-562-4597

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Drug Facts

Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

How Supplied (HOW SUPPLIED)

Product: 50090-3021

NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE

Sodium Bicarbonate (sodium bicarbonate)

Advanced Ingredient Data

[{"name": "BICARBONATE ION", "unii": "HN1ZRA3Q20", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms", "34068-7": "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", "34071-1": "Warnings 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. 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. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use.", "42229-5": "11790-11-16 REV 11/16 Manufactured for: Manufactured by: Rising Pharmaceuticals, Inc. Contract Pharmacal Corp. Allendale, NJ 07401 Hauppauge, NY 11788 Lot No.: Exp. Date:", "44425-7": "Other Information: Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.", "50565-1": "Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.", "51727-6": "Inactive Ingredients: Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.", "53413-1": "Questions? 1-866-562-4597", "55105-1": "Purpose Antacid", "55106-9": "Drug Facts Active ingredients (in each tablet) Sodium Bicarbonate 10 gr (650mg)", "HOW SUPPLIED": "Product: 50090-3021 NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE"}