Sodium Bicarbonate 10 Gr Tablets, Usp

Sodium Bicarbonate 10 Gr Tablets, Usp
SPL v1
SPL
SPL Set ID f7ebb41a-d483-442a-95a0-47706cf3ee9a
Route
ORAL
Published
Effective Date 2020-07-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (650 mg)
Inactive Ingredients
Croscarmellose Sodium Cellulose, Microcrystalline 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

Description

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


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
Description

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

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)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 10 gr
60 71610-438-53
90 71610-438-60
120 71610-438-70
180 71610-438-80
360 71610-438-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20200706JH

Principal Display Panel 10 Gr

NDC 71610-438 - Sodium Bicarbonate 10 gr Tablets


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)

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)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 10 gr
60 71610-438-53
90 71610-438-60
120 71610-438-70
180 71610-438-80
360 71610-438-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20200706JH

Principal Display Panel 10 Gr (PRINCIPAL DISPLAY PANEL - 10 gr)

NDC 71610-438 - Sodium Bicarbonate 10 gr Tablets


Advanced Ingredient Data


Raw Label Data

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