Label: ALKA-SELTZER ORIGINAL FLAVOR- buffered aspirin, effervescent tablet tablet, effervescent
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NDC Code(s):
66715-6403-2,
66715-6403-7,
66715-6403-8,
66715-6503-2, view more66715-9603-2, 66715-9603-3
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
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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 directed
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 if
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
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
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Directions
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 8 tablets in 24 hours children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments
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SPL UNCLASSIFIED SECTION
Bayer
Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981
This product is repackaged by Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404;1-877-507-6516 (M-F 8AM-4:30PM CST), from a product manufactured by Bayer. 97033C-US-03-22
“Bayer, the Bayer Cross and Alka-Seltzer are registered trademarks of Bayer, used with permission.”
Made in Mexico - PDP/Package
- Alka-Seltzer Original, CVP HEALTH PDP/Package
- Alka-Seltzer Original, Travel BASIX PDP/Package
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER ORIGINAL FLAVOR
buffered aspirin, effervescent tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6503 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 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:66715-6503-2 2 in 1 CARTON 05/06/2022 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 05/06/2022 ALKA-SELTZER ORIGINAL FLAVOR
buffered aspirin, effervescent tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9603 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 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:66715-9603-2 2 in 1 CARTON 12/01/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9603-3 3 in 1 CARTON 12/01/2022 2 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 12/01/2022 ALKA-SELTZER ORIGINAL FLAVOR
buffered aspirin, effervescent tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6403 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 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:66715-6403-2 2 in 1 CARTON 11/28/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-6403-7 25 in 1 CARTON 04/19/2022 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-6403-8 30 in 1 CARTON 04/19/2022 3 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 04/19/2022 Labeler - Lil' Drug Store Products, Inc. (093103646)