Label: ALKA-SELTZER HEARTBURN- anhydrous citric acid and sodium bicarbonate granule, effervescent
- NDC Code(s): 0280-4085-36
- Packager: Bayer HealthCare LLC, Consumer Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each tablet) Purpose Anhydrous citric acid 1000 mg Antacid Sodium bicarbonate (heat-treated) 1940 mg Antacid
for the relief of
- acid indigestion
- upset stomach associated with these symptoms
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- 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 information
- each tablet contains: sodium 575 mg
- phenylketonurics: contains phenylalanine 5.6 mg per tablet
- store at room temperature. Avoid excessive heat.
- Alka-Seltzer Heartburn in water contains the antacid sodium citrate as the principal active ingredient
- Inactive ingredients
acesulfame potassium, aspartame, flavors, magnesium stearate, mannitolClose
- Questions or comments?
1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.comClose
- PRINCIPAL DISPLAY PANEL - 36 Tablets Carton
FAST, COOLING RELIEF OF:
- INGREDIENTS AND APPEARANCE
anhydrous citric acid and sodium bicarbonate granule, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-4085 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 1000 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Bicarbonate 1940 mg Product Characteristics Color WHITE Score Shape ROUND Size Flavor Imprint Code ALKA;SELTZER;HR Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-4085-36 36 in 1 CARTON 1 1 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/02/2010 Labeler - Bayer HealthCare LLC, Consumer Care (785159372)