FDA Label for Alka-seltzer Original Flavor
View Indications, Usage & Precautions
Alka-seltzer Original Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Active ingredients (in each tablet)
Buffered aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Purpose
Pain reliever/fever reducer
Uses
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscle pain
- backache
- toothache
- menstrual pain
- colds
- minor pain of arthritis
- temporarily reduces fever
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.
Allergy Alert
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
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
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
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
Ask A Doctor Or Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- diabetes
- gout
- arthritis
Stop Use And Ask A Doctor
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 gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
If Pregnant
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
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 and children 12 years and over | 2 tablets every 4 hours, or as directed by a doctor | do not exceed 8 tablets in 24 hours |
adults 60 years and over | 2 tablets every 4 hours, or as directed by a doctor | do not exceed 8 tablets in 24 hours |
children under 12 years | ask a doctor |
Other Information
Other information
- each tablet contains: sodium 568 mg
- store at room temperature. Avoid excessive heat.
- Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate
Inactive Ingredients
Inactive ingredients
anhydrous citric acid, sodium bicarbonate
Questions Or Comments
Questions or comments?
1-800-986-0369 (Mon - Fri 9AM - 5PM EST)
Other
Bayer
Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981
This product is repackaged by Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404;
1-877-507-6516 (M-F 8AM-4:30PM CST), from a product manufactured by Bayer. 97033C-US-03-22
“Bayer, the Bayer Cross and Alka-Seltzer are registered trademarks of Bayer, used with permission.”
Made in Mexico
Pdp/Package
[Bayer cross]
Alka-
Seltzer ®
Buffered aspirin (NSAID) /
Pain Reliever/fever reducer
Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain
ORIGINAL FLAVOR
6
Effervescent Tablets
(3 - 2 count pouches)
[Lil' Drug Store logo]
* Please review the disclaimer below.