Sodium Bicarbonate 10 Gr Tablets, Usp

Sodium Bicarbonate 10 Gr Tablets, Usp
SPL v104
SPL
SPL Set ID 4493d7c5-f2c3-416e-a5c1-35398fc7f61d
Route
ORAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (650 mg)
Inactive Ingredients
Microcrystalline Cellulose Corn Oil

Identifiers & Packaging

Pill Appearance
Imprint: AS3 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-20

Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

How Supplied

NDC 63629-8775-1: 1000 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Recent Major Changes


DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

NDC 63629-8775-1: 1000 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 42229-5

Rev. 11/19



Manufactured for:

Rising Pharma Holdings, Inc.

2 Tower Center Blvd,

East Brunswick, NJ 08816



Manufactured by:

Aurex Laboratories LLC,

East Windsor, NJ 08520

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:   Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

Section 51945-4

Sodium Bicarbonate 650 mg Tablet

Section 53413-1

Questions or Comments? 1-866-562-4597

Section 55105-1

Purpose

Antacid

Section 55106-9

Drug Facts

Active ingredients (in each tablet)


Sodium Bicarbonate 10 gr (650mg)


Structured Label Content

Recent Major Changes (34066-1)


DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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)

Rev. 11/19



Manufactured for:

Rising Pharma Holdings, Inc.

2 Tower Center Blvd,

East Brunswick, NJ 08816



Manufactured by:

Aurex Laboratories LLC,

East Windsor, NJ 08520

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:   Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

Section 51945-4 (51945-4)

Sodium Bicarbonate 650 mg Tablet

Section 53413-1 (53413-1)

Questions or Comments? 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)

NDC 63629-8775-1: 1000 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504


Advanced Ingredient Data


Raw Label Data

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