Alka Seltzer Plus Cold Day And Night Effervescent Tablet
FDA Label NDC 71992-154

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sincronia Logistica, S.a. De C.v. for the product Alka Seltzer Plus Cold Day And Night Effervescent (NDC 71992-154). 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 active ingredients (in each tablet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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.

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

* Please review the disclaimer below.