Label: ALKA-SELTZER- aspirin, citric acid, sodium bicarbonate effervescent tablet tablet, effervescent
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- NDC Code(s): 66715-5106-0
- Packager: Lil' Drug Store Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0280-4000
- 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.
Drug Label Information
Updated March 17, 2022
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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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
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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.
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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(NDC:0280-4000) 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 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 not final part343 01/17/2008 Labeler - Lil' Drug Store Products, Inc. (093103646)
