Pouch Header/Pdp
Do not use if pouch is torn or open.
Alka-Seltzer ®
Buffered aspirin (NSAID)/Pain reliever/fever reducer
ORIGINAL FLAVOR
[Bayer logo]
Fast Relief
2 EFFERVESCENT TABLETS
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Alka-seltzer (NDC 66715-5206). 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 pouch header/pdp, active ingredient, purpose, uses, warnings, reye's syndrome, allergy alert, stomach bleeding warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Do not use if pouch is torn or open.
Alka-Seltzer ®
Buffered aspirin (NSAID)/Pain reliever/fever reducer
ORIGINAL FLAVOR
[Bayer logo]
Fast Relief
2 EFFERVESCENT TABLETS
Active ingredient (in each tablet)
Buffered aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
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:
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 Fully dissolve 2 tablets in 4 ounces of water before taking. Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 4 tablets in 24 hours. Children under 12 years: consult a doctor.
Other information
Inactive ingredients anhydrous citric acid, sodium bicarbonate
Questions? 1-800-986-0369 Dist. By Bayer Healthcare LLC, Whippany, NJ 07981
[Bayer logo]
Alka-
Seltzer ®
Buffered aspirin (NSAID)/
Pain reliever/fever reducer
ORIGINAL FLAVOR
15 PACKETS OF
2 EFFERVESCENT TABLETS
[UPC]
* Please review the disclaimer below.