Active Ingredient
Sodium bicarbonate 2,485 mg
Dr Sana Alivio Digestivo Naranja Granule, Effervescent
FDA Label NDC 84178-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Evi Labs for the product Dr Sana Alivio Digestivo Naranja (NDC 84178-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
For relief of heartburn, acid indigestion, upset stomach associated with these symptoms
Warnings
STOMACH WARNING: To avoid serious injury, do not take until the powder 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.
Do Not Use
Unless directed by a doctor
If you are on a sodium-restricted diet.
If you have kidney disease
If you have heart disease
If you have high blood pressure
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- kidney disease
- a sodium-restricted diet
- are pregnant or breast feeding
Ask A Doctor Or Pharmacist Before Use If You Are
Taking a prescription drug. Antacids may interact with certain prescription drugs.
When Using This Product
Do not take more than 6 packets in 24 hours if you are between 12 and 60 years old and 3 packets in 24 hours if you are over 60 years old or do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
Stop Use And Ask A Doctor If
- Symptoms persist
- Symptoms worsen
- You experience severe stomach pain
If Pregnant Or Breast-Feeding,
Please consult your doctor before using this product.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Directions
Directions: Adults and children 12 years and older: dissolve 1 packet in ½ glass (4 fl oz) of water every 4 hours, or as directed by a doctor. Adults and children 12 to 60 years of age: do not exceed 6 packets in 24 hours. Adults 60 years of age and over: do not exceed 3 packets in 24 hours. Children under 12 years of age: do not use.
Other Information
Each packet contains 680 mg of sodium.
Store in a cool, dry place at 20°–25°C (68°–77°F)
Inactive Ingredients
Citric acid, Natural orange flavor powder, tartaric acid, sucrose, silicon dioxide, and Beta- carotene as colorant.
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