Alka-Seltzer Hangover Relief
Alka-Seltzer Hangover Relief by
Drug Labeling and Warnings
Alka-Seltzer Hangover Relief by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ALKA-SELTZER HANGOVER RELIEF- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
Navajo Manufacturing Company Inc.
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.
----------
Alka-Seltzer Hangover Relief
Active Ingredients (in each tablet)
Aspirin 500 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
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
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.
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
| 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
● 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
| ALKA-SELTZER HANGOVER RELIEF
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Navajo Manufacturing Company Inc. (091917799) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Navajo Manufacturing Company Inc. | 136941411 | relabel(67751-218) , repack(67751-218) | |