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
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 28, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- facial swelling
- asthma (wheezing)
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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- 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
INGREDIENTS AND APPEARANCE
ALKA-SELTZER EXTRA STRENGTH
anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent
Product 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 not final part343 04/11/2011 Labeler - Bayer HealthCare LLC. (112117283)