Active Ingredients
Active ingredients (in each tablet)
Buffered aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Alka-seltzer Original Flavor (NDC 66715-6403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each tablet)
Buffered aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
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:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking a prescription drug for
Stop use and ask a doctor if
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
| 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
Inactive ingredients
anhydrous citric acid, sodium bicarbonate
Questions or comments?
1-800-986-0369 (Mon - Fri 9AM - 5PM EST)
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
[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.