ALKA-SELTZER HANGOVER RELIEF- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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.

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

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

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

INGREDIENTS AND APPEARANCE

ALKA-SELTZER HANGOVER RELIEF 
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-218(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: 67751-218-01	2 in 1 CARTON	02/21/2022	12/01/2023
1		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 not final	part343	02/21/2022	12/01/2023

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-218) , repack(67751-218)