Label: ALKA-SELTZER- buffered aspirin tablet, effervescent
- NDC Code(s): 66715-5206-0
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- Pouch Header/PDP
- Active ingredient
- Purpose
- Uses
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Warnings
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 directedStomach bleeding warning: This product contains an NSAID, which
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- diabetes
- gout
- arthritis
Stop use and ask a doctor
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor
because it may cause problems in the unborn child or complications during delivery. -
Directions
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?
- Alka-Seltzer® Gravity Sleeve (unit dose) - PDP/Label
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER
buffered aspirin tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5206 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-5206-0 15 in 1 BOX, UNIT-DOSE 06/01/2023 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 M013 06/01/2023 Labeler - Lil' Drug Store Products, Inc. (093103646)