sodium bicarbonate 10 gr (650 mg), 70795-1190

sodium bicarbonate 10 gr (650 mg), 70795-1190
SPL v9
SPL
SPL Set ID 897dbb09-fb47-4e03-8cae-bf76d48a7a03
Route
oral
Published
Effective Date 2021-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sodium cation (650 mg)
Inactive Ingredients
starch, corn mineral oil

Identifiers & Packaging

Pill Appearance
Imprint: G35 Shape: round Color: white Size: 11 mm Score: 2
Marketing Status
otc monograph drug active Since 2017-10-02

Purpose

Antacid

Description

Sodium bicarbonate 10 gr (650 mg)


Medication Information

Warnings

Active Ingredient

Sodium bicarbonate 10 gr (650 mg)

Uses

Relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Purpose

Antacid

Directions

Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets.

Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

D0 NOT EXCEED RECOMMENDED DOSE

Not recommended for children.

Other Information
  • each tablet contains : sodium 178 mg (7.74 meg)
  • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP
Inactive Ingredients

Pregelatinized starch, NF and mineral oil, USP

Description

Sodium bicarbonate 10 gr (650 mg)

Section 42229-5

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

Section 51945-4

Do Not Use
  • this product if you are on a sodium-restricted diet unless directed by a doctor
  • Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
  • As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product
Stomach Warning
  • TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK
  • Consult a doctor if severe stomach pain occurs after taking this product.
Questions Or Comments?

Call toll free 1-888-266-8818

Drug Interaction Precaution

Keep This and All Drugs Out of the Reach of Children

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


Structured Label Content

Warnings

Active Ingredient (Active ingredient (in each tablet))

Sodium bicarbonate 10 gr (650 mg)

Uses

Relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Purpose

Antacid

Directions

Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets.

Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

D0 NOT EXCEED RECOMMENDED DOSE

Not recommended for children.

Other Information (Other information)
  • each tablet contains : sodium 178 mg (7.74 meg)
  • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP
Inactive Ingredients (Inactive ingredients)

Pregelatinized starch, NF and mineral oil, USP

Section 42229-5 (42229-5)

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • this product if you are on a sodium-restricted diet unless directed by a doctor
  • Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
  • As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product
Stomach Warning
  • TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK
  • Consult a doctor if severe stomach pain occurs after taking this product.
Questions Or Comments? (Questions or comments?)

Call toll free 1-888-266-8818

Drug Interaction Precaution

Keep This and All Drugs Out of the Reach of Children (KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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