FDA Label for Alka-seltzer Hangover Relief

Other

Drug Facts

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Otc - Active Ingredient

Active Ingredients (in each tablet)
Aspirin 500 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Otc - Purpose

Pain reliever
Alertness aid/pain reliever aid

Uses

Uses

• for the temporary relief of minor aches and pains associated with a hangover
• helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
• for temporary relief of headaches, body aches, and pain alone

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) ● 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.

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 ● 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
  • 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
  
  

Otc - Pregnancy 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

Other Information

● each tablet contains: potassium 115 mg
● each tablet contains: sodium 371 mg
● Phenylketonurics: Contains Phenylalanine 5.4 mg per tablet
● store at room temperature. Avoid excessive heat

Inactive Ingredients

anhydrous citric acid, aspartame, dimethicone, docusate sodium, FD&C red No. 40, FD&C yellow No. 6, flavor, mannitol, potassium
bicarbonate, povidone, sodium benzoate, sodium bicarbonate, sucralose

Questions Or Comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

Principal Display Panel - 20 Tablet Carton

88056531_ALKA-SELTZER_Hangover_Relief_Orange_Tablet_20ct_Ctn_r3.jpg - 88056531 ALKA SELTZER Hangover Relief Orange Tablet 20ct Ctn r3

HANGOVER RELIEF

orange fizz

FAST RELIEF OF
headache, body aches
mental fatigue

20EFFERVESCENT TABLETS
10 - 2 count pouches