ALKA SELTZER PLUS Cold Day and Night Effervescent

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 PLUS Cold Day and Night Effervescent
Generic name
ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
Manufacturer
Sincronia Logistica, S.A. de C.V.
Product type
HUMAN OTC DRUG
SPL set ID
c478df69-823a-4112-8f44-323249a9f38f
SPL ID
086318bd-5067-477e-e063-6294a90ab2dd
Version
4
Effective date
2023-10-23
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:24:04
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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. Reye’s syndrome: Aspirin may cause a severe allergic reaction which may include: Allergy alert: ● hives ● facial swelling ● asthma (wheezing) ● shock This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning: ● 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 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. Sore throat warning: Do not use to sedate children. Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age 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 ● thyroid disease ● diabetes ● cough with excessive phlegm (mucus) ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a sodium-restricted diet Ask a doctor or pharmacist before use if you are ● taking a prescription drug for ● gout ● diabetes ● arthritis ● taking sedatives or tranquilizers When using this product ● do not exceed recommended dosage ● may cause marked drowsiness ● avoid alcoholic drinks ● alcohol, sedatives, and tranquilizers may increase drowsiness ● be careful when driving a motor vehicle or ● 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.

Reported adverse events (FAERS/openFDA)#

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