Label: ALKA-SELTZER- aspirin, citric acid, sodium bicarbonate effervescent tablet tablet, effervescent
- NDC Code(s): 66715-5106-0
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 14, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Pouch Header
- ACTIVE INGREDIENT
- Uses
-
Warnings
Reye's syndrome
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert
Allergy alert: Aspirin may cause a severe allergic reaction which may
include:• hives
• facial swelling
• asthma (wheezing)
• shock
Stomach bleeding warning
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
• are age 60 or older • have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directedDo not use
• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredientsAsk a doctor before use if
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic • you have asthma
• you have a sodium-restricted dietAsk a doctor or pharmacist before use if you are
• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
• taking a prescription drug for diabetes, gout, or arthritisStop use and ask a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding
• feel faint • vomit blood • have bloody or black stools
• have stomach pain that does not get better
• symptoms get worse or last more than 10 days
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs• new symptoms occur
-
Directions
Fully dissolve 2 tablets in 4 ounces of water before taking.
Adults and children 12 years and over: take 2 tablets every 4 hours,or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 2 tablets every 4 hours,or as directed by a doctor. Do not exceed 4 tablets in 24 hours. Children under 12 years: consult a doctor.
- Other information
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER
aspirin, citric acid, sodium bicarbonate effervescent tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5106 Route of Administration ORAL 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 ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-5106-0 15 in 1 BOX, UNIT-DOSE 01/17/2008 06/01/2026 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M001 01/17/2008 06/01/2026 Labeler - Lil' Drug Store Products, Inc. (093103646)