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
- Marketing Status: OTC monograph 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 May 18, 2023
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 final M013 02/21/2022 Labeler - Bayer HealthCare LLC. (112117283)
