Alka-seltzer Hangover Relief

Alka-seltzer Hangover Relief
SPL v16
SPL
SPL Set ID dc235b06-999e-221d-e053-2a95a90a0ce1
Route
ORAL
Published
Effective Date 2022-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (65 mg) Aspirin (500 mg)
Inactive Ingredients
Sodium Bicarbonate Sucralose Sodium Benzoate Fd&c Yellow No. 6 Aspartame Anhydrous Citric Acid Docusate Sodium Dimethicone 100 Fd&c Red No. 40 Potassium Bicarbonate Calcium Silicate Povidone Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: A;S Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-21

Description

Drug Facts


Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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.


Section 55105-1

Pain reliever

Alertness aid/pain reliever aid

Section 55106-9

Active Ingredients (in each tablet)

Aspirin 500 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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.

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

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
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

● hives ● facial swelling ● asthma (wheezing) ● shock

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.

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.

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)

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
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
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
Principal Display Panel 20 Tablet Carton

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

● diabetes ● gout ● arthritis


Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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.


Section 55105-1 (55105-1)

Pain reliever

Alertness aid/pain reliever aid

Section 55106-9 (55106-9)

Active Ingredients (in each tablet)

Aspirin 500 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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.

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

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
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

● hives ● facial swelling ● asthma (wheezing) ● shock

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.

Caffeine Warning (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.

Other Information (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 (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? (Questions or comments?)

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

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
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
Stop Use and Ask A Doctor If (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
Principal Display Panel 20 Tablet Carton (PRINCIPAL DISPLAY PANEL - 20 Tablet Carton)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

● diabetes ● gout ● arthritis


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)