De La Cruz ®

De La Cruz ®
SPL v10
SPL
SPL Set ID fc469943-9749-45ee-93f7-90fdbcdc7215
Route
ORAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (2.6 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-25

Description

Drug Facts

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Drug Facts

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 50570-1

Do not use in children under 12 years of age.

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

FOR ORAL USE ONLY

Questions

1-800-858-3889

Directions
  • take ½ level teaspoon in ½ glass (4 fl. oz.) of water every 2 hours up to 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 and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period.
Children under 12 years Do not use.

Do not exceed recommended dosage. See warnings.

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 FULL FROM FOOD OR DRINK.

Other Information
  • each 1/2 teaspoon dose contains: sodium 716 mg
Inactive Ingredient

none

Stop Use and Ask A Doctor If
  • you have used the maximum dosage for 2 weeks
  • severe stomach pain occurs after using this product
Ask A Doctor Before Use If You Have
  • a sodium-restricted diet.
Principal Display Panel 113 G Bottle Label

De La Cruz ®

OVER

40

DOSES

Sodium

Bicarbonate

USP

- Oral Powder -

SUGAR

FREE

Antacid

NET WT 4 OZ (113g)

Active Ingredient (in Each Dose = 1/2 Teaspoon)

Sodium bicarbonate USP 2,616 mg


Structured Label Content

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use in children under 12 years of age.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Antacid

Warnings

FOR ORAL USE ONLY

Questions

1-800-858-3889

Directions
  • take ½ level teaspoon in ½ glass (4 fl. oz.) of water every 2 hours up to 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 and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period.
Children under 12 years Do not use.

Do not exceed recommended dosage. See warnings.

Stomach Warning (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 FULL FROM FOOD OR DRINK.

Other Information (Other information)
  • each 1/2 teaspoon dose contains: sodium 716 mg
Inactive Ingredient

none

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have used the maximum dosage for 2 weeks
  • severe stomach pain occurs after using this product
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sodium-restricted diet.
Principal Display Panel 113 G Bottle Label (PRINCIPAL DISPLAY PANEL - 113 g Bottle Label)

De La Cruz ®

OVER

40

DOSES

Sodium

Bicarbonate

USP

- Oral Powder -

SUGAR

FREE

Antacid

NET WT 4 OZ (113g)

Active Ingredient (in Each Dose = 1/2 Teaspoon) (Active ingredient (in each dose = 1/2 teaspoon))

Sodium bicarbonate USP 2,616 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)