ALKA SELTZER PLUS Cold Day and Night Effervescent

ALKA SELTZER PLUS Cold Day and Night Effervescent is an FDA-registered drug product whose active ingredient is ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE. It is labelled by Sincronia Logistica, S.A. de C.V. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71992-154, application M012, label effective 20231023. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE are most often described in connection with: temporarily relieves, symptoms due, cold minor, pains headache, runny nose, sinus congestion, pressure cough, sneezing sore. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • headache • runny nose • sinus congestion and pressure • cough • sneezing • sore throat • nasal congestion • temporarily reduces fever

Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use

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.

What is ALKA SELTZER PLUS Cold Day and Night Effervescent used for?
Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • headache • runny nose • sinus congestion and pressure • cough • sneezing • sore throat • nasal congestion • temporarily reduces fever

Who makes ALKA SELTZER PLUS Cold Day and Night Effervescent?
Sincronia Logistica, S.A. de C.V. is the labeler of record for ALKA SELTZER PLUS Cold Day and Night Effervescent.

What form does ALKA SELTZER PLUS Cold Day and Night Effervescent come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ALKA SELTZER PLUS Cold Day and Night Effervescent prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has ALKA SELTZER PLUS Cold Day and Night Effervescent been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.