Other
Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Plus Cold Medicine Sparkling Original (NDC 0280-1400). 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 other, otc - purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, sore throat warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Aspirin 325 mg (NSAID)
nonsteroidal anti-inflammatory drug | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Phenylephrine bitartrate 7.8 mg | Nasal decongestant |
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.
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
Do not use
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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.
acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
1-800-986-0369 (Mon-Fri 9AM – 5PM EST)
Alka-
Seltzer
PLUS
®
Aspirin (NSAID) / Pain reliever-
fever reducer • Chlorpheniramine
maleate / Antihistamine • Phenylephrine
bitartrate / Nasal decongestant
COLD
FORMULA
SPARKLING
ORIGINAL
Nasal Congestion • Runny Nose
Headache & Body Ache
Sore Throat • Sinus Pressure
36 EFFERVESCENT TABLETS
* Please review the disclaimer below.