FDA Label for Alka-seltzer Heartburn Relief Extra Strength
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-seltzer Heartburn Relief Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc. 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
Otc - Active Ingredient
Anhydrous citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1976 mg
Otc - Purpose
Antacid
Antacid
Indications & Usage
Uses for the relief of
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Warnings
Warnings
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
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.
Otc - When Using
When using this product do not exceed recommended dosage
Otc - Stop Use
Stop use and ask a doctor if you have taken the maximum dose for 2 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over | 2 tablets every 4 hours as needed, or as directed by a doctor | do not exceed 8 tablets in 24 hours |
adults 60 years and over | 2 tablets every 4 hours as needed, or as directed by a doctor | do not exceed 4 tablets in 24 hours |
children under 12 years | consult a doctor |
Other Safety Information
Other information
● each tablet contains: sodium 586 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Extra Strength in water contains the antacid
sodium citrate as the principal active ingredient
Inactive Ingredient
Inactive ingredients
magnesium stearate, mannitol
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Package Label.Principal Display Panel
ALKA-SELTZER
Fast 4-in-1
Relief of:
Heartburn
Sour Stomach
Acid Indigestion
Upset Stomach
HEARTBURN RELIEF
EXTRA STRENGTH
24 EFFERVESCENT TABLETS
(12 - 2 count pouches)
* Please review the disclaimer below.