FDA Label for Sodium Bicarbonate Antacid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH DOSE = 1/2 TEASPOON)
- PURPOSE
- USES
- WARNINGS
- STOMACH WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- QUESTIONS OR COMMENTS
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 113 G BOTTLE LABEL
Sodium Bicarbonate Antacid Product Label
The following document was submitted to the FDA by the labeler of this product Dannso Corp./d.b.a. Essential Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient (In Each Dose = 1/2 Teaspoon)
Sodium bicarbonate USP 2,616 mg
Purpose
Antacid
Uses
Relieves:
- heartburn
- sour stomach
- acid indigestion
- upset stomach associated with these symptoms
Warnings
FOR ORAL USE ONLY
Do not use if Tamper Evident Seal is missing or broken.
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.
Otc - Do Not Use
Do not use in children under 12 years of age.
Ask A Doctor Before Use If You Have
- a sodium-restricted diet.
Otc - Ask Doctor/Pharmacist
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 weeks
- severe stomach pain occurs after using this product
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center immediately.
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.
Other Information
- each 1/2 teaspoon dose contains: sodium 716 mg
Questions Or Comments
Distributed by
Essential Products Miami FL 33126
Made in U.S.A.
Questions
1-800-858-3889
Principal Display Panel - 113 G Bottle Label
De La Cruz®
Sodium
Bicarbonate
USP
- Oral Powder -
Antacid
NET WT 4 OZ (113 g)
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