Sodium Bicarbonate Tablets, Usp 10gr (650mg)

Sodium Bicarbonate Tablets, Usp 10gr (650mg)
SPL v4
SPL
SPL Set ID e206c240-55c2-2d00-e053-2a95a90a1779
Route
ORAL
Published
Effective Date 2022-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (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 2022-06-24

Description

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


Medication Information

Recent Major Changes

TAMPER EVIDENT: 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

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

Section 42229-5

Rev.: 04/2022

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

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 53413-1

Questions or Comments?

Phone +1-855-642-2594

Section 55105-1

Antacid

Section 55106-9

Drug Facts

Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

Sodium Bicarbonate Tablets,usp 10gr (650mg) 1000 Tablets

NDC : 24689-137-01

Sodium

Bicarbonate 10 gr TABLETS, USP

Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets


Structured Label Content

Recent Major Changes (34066-1)

TAMPER EVIDENT: 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.: 04/2022

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

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 53413-1 (53413-1)

Questions or Comments?

Phone +1-855-642-2594

Section 55105-1 (55105-1)

Antacid

Section 55106-9 (55106-9)

Drug Facts

Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

Sodium Bicarbonate Tablets,usp 10gr (650mg) 1000 Tablets (Sodium Bicarbonate Tablets,USP 10gr (650mg)-1000 Tablets)

NDC : 24689-137-01

Sodium

Bicarbonate 10 gr TABLETS, USP

Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets


Advanced Ingredient Data


Raw Label Data

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