Drugplain

Alka-Seltzer Plus Cold Orange Zest 325 mg/1

Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate · TABLET, EFFERVESCENT · Bayer HealthCare LLC.

No Recall History
Plain English

Alka-Seltzer Plus Cold Orange Zest is an over-the-counter effervescent tablet that combines aspirin (a pain reliever and anti-inflammatory), chlorpheniramine (an antihistamine), and phenylephrine (a decongestant) to help relieve multiple cold symptoms including congestion, runny nose, sneezing, and aches. This medication is dissolved in water before taking by mouth.

Key Facts

Brand Name
Alka-Seltzer Plus Cold Orange Zest
Generic Name
Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate
NDC Code (Product)
0280-1510
Manufacturer
Bayer HealthCare LLC.
Strength
325 mg/1
Dosage Form
TABLET, EFFERVESCENT
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
07/15/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

adverse reaction1 reports
dyspnoea1 reports
hypersensitivity1 reports
malaise1 reports
muscle tightness1 reports
oedema peripheral1 reports
swelling face1 reports
throat tightness1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

Warnings Reye’s syndrome: 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. Allergy alert : Aspirin may cause a severe allergic reaction which may include: ● hives ● facial swelling ● asthma (wheezing) ● shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● 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 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. Do not use to sedate children.

Frequently Asked Questions

What is Alka-Seltzer Plus Cold Orange Zest used for?

Alka-Seltzer Plus Cold Orange Zest is an over-the-counter effervescent tablet that combines aspirin (a pain reliever and anti-inflammatory), chlorpheniramine (an antihistamine), and phenylephrine (a decongestant) to help relieve multiple cold symptoms including congestion, runny nose, sneezing, and aches. This medication is dissolved in water before taking by mouth.

Is Alka-Seltzer Plus Cold Orange Zest a controlled substance?

Alka-Seltzer Plus Cold Orange Zest is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Plus Cold Orange Zest?

The generic name for Alka-Seltzer Plus Cold Orange Zest is Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate. There are 12 other brand versions of Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate.

What is the NDC code for Alka-Seltzer Plus Cold Orange Zest 325 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Cold Orange Zest 325 mg/1 is 0280-1510, listed by Bayer HealthCare LLC..

Product NDC

0280-1510

Package NDC

0280-1510-20

Other Aspirin, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)