Label: ALKA SELTZER ORIGINIAL 1S BLISTER PACK- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
- NDC Code(s): 50269-307-06
- Packager: JC World Bell Wholesale Co., Inc.
- This is a repackaged label.
- Source NDC Code(s): 0280-4000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each tablet)
- Uses
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Warnings
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. Reye's syndrome:
Aspirin may cause a severe allergic reaction which may include: Allergy alert:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:
- hives
- facial swelling
- asthma (wheezing)
- shock
- 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 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 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 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 or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ALKA SELTZER ORIGINIAL 1S BLISTER PACK
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50269-307(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:50269-307-06 6 in 1 BOX 10/30/2019 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 10/30/2019 Labeler - JC World Bell Wholesale Co., Inc. (805257581) Establishment Name Address ID/FEI Business Operations Bayer HealthCare LLC 072827066 manufacture(50269-307) Establishment Name Address ID/FEI Business Operations JC World Bell Wholesale Co., Inc. 805257581 repack(50269-307)
