Label: ALKA-SELTZER HANGOVER RELIEF- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
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NDC Code(s):
0280-0084-01,
0280-0084-02,
0280-0084-03,
0280-0084-04, view more0280-0084-05
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Warnings
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:
● hives ● facial swelling ● asthma (wheezing) ● shock
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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of
coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heart beat.
● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
continues to recur, consult a doctor.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:
● hives ● facial swelling ● asthma (wheezing) ● shockStomach 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
Caffeine warning
The recommended dose of this product contains about as much caffeine as a cup of
coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heart beat.
● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
continues to recur, consult a doctor.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
taking a prescription drug for
● diabetes ● gout ● 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
- pain lasts for more than 10 days or gets worse
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
Adults 18 years and over 2 tablets every 6 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours Adults 60 years and over 2 tablets every 6 hours as needed, or as directed by a doctor do not exceed 5 tablets in 24 hours Children under 18 years consult a doctor - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 20 Tablet Carton
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER HANGOVER RELIEF
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0084 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DOCUSATE SODIUM (UNII: F05Q2T2JA0) DIMETHICONE 100 (UNII: RO266O364U) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code A;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0084-01 10 in 1 CARTON 02/21/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0084-02 18 in 1 CARTON 04/19/2023 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0280-0084-03 60 in 1 CARTON 04/19/2023 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0280-0084-04 2 in 1 CARTON 04/19/2023 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0280-0084-05 1600 in 1 BOX 05/23/2023 5 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 02/21/2022 Labeler - Bayer HealthCare LLC. (112117283)