Sodium Bicarbonate Antacid

Sodium Bicarbonate Antacid
SPL v3
SPL
SPL Set ID 6efb4da0-03ae-4df6-acd7-e8023d20d4b3
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (2.616 g)
Inactive Ingredients
Sodium Cation

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-01

Description

Active ingredient (in each dose=1/2 teaspoon)        Purpose Sodium bicarbonate USP 2,616 mg ............................ Antacid


Medication Information

Warnings and Precautions

Warnings

FOR ORAL USE ONLY

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.

Do not use in children under 12 years of age.

Ask a doctor or pharmacist before use if you have a sodium-restricted diet.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • you have used the maximum dosage for 2 wekks
  • sever stomach pain occurs after using this product
Indications and Usage

Uses

Relieves: 

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these syptoms
Dosage and Administration

Directions

  • Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
 Age  Maximum Dosage
 Adults 60 years and over Do not exceed three doses of 1/2 teaspoon in a 24 hour period 
 Adults and children 12 years of age and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period 
Children under 12 years  Do not use 

Description

Active ingredient (in each dose=1/2 teaspoon)        Purpose Sodium bicarbonate USP 2,616 mg ............................ Antacid

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive Ingredients:

Section 51945-4

Section 53413-1

Questions:

1-800-560-5223 M-F 9AM to 4PM Eastern

Menper Distributors Inc.

www.menperdistributors.com

Section 53414-9

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

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each dose=1/2 teaspoon)        Purpose

Sodium bicarbonate USP 2,616 mg ............................ Antacid


Structured Label Content

Indications and Usage (34067-9)

Uses

Relieves: 

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these syptoms
Dosage and Administration (34068-7)

Directions

  • Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
 Age  Maximum Dosage
 Adults 60 years and over Do not exceed three doses of 1/2 teaspoon in a 24 hour period 
 Adults and children 12 years of age and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period 
Children under 12 years  Do not use 

Warnings and Precautions (34071-1)

Warnings

FOR ORAL USE ONLY

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.

Do not use in children under 12 years of age.

Ask a doctor or pharmacist before use if you have a sodium-restricted diet.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • you have used the maximum dosage for 2 wekks
  • sever stomach pain occurs after using this product
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients:

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions:

1-800-560-5223 M-F 9AM to 4PM Eastern

Menper Distributors Inc.

www.menperdistributors.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each dose=1/2 teaspoon)        Purpose

Sodium bicarbonate USP 2,616 mg ............................ Antacid


Advanced Ingredient Data


Raw Label Data

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