Label: ALKA-SELTZER EXTRA STRENGTH- anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent
- NDC Code(s): 0280-0211-24
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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: Aspirin may cause a severe allergic reaction which may include
- hives
- facial swelling
- asthma (wheezing)
- shock
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 directed
Do 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 ingredients
Ask 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 diet
Ask 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 anticoagulation (blood thinning), diabetes, gout, or arthritis
Stop 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
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Directions
- fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 7 tablets in 24 hours adults 60 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 3 tablets in 24 hours children under 12 years consult a doctor - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 24 Tablets Carton
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER EXTRA STRENGTH
anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0211 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 SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1985 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg Inactive Ingredients Ingredient Name Strength LEMON (UNII: 24RS0A988O) Product Characteristics Color white (White tablet) Score no score Shape ROUND Size 25mm Flavor Imprint Code ALKA;SELTZER;EX;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0211-24 12 in 1 CARTON 04/18/2011 1 2 in 1 PACKET; 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 04/11/2011 Labeler - Bayer HealthCare LLC. (112117283)