ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Bayer HealthCare LLC.
Product type
HUMAN OTC DRUG
SPL set ID
512af63d-2f09-4baa-e063-6394a90a86bd
SPL ID
512af63d-2f08-4baa-e063-6394a90a86bd
Version
1
Effective date
2026-05-06
Source export date
2026-10-27
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 19:58:32
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 capsules in 24 hours, which is the maximum daily amount for this product · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore throat warning: 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.