aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve, Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night, Alka-Seltzer Plus Severe Cold Night PowerFast Fizz. Available dosage forms: kit, tablet, effervescent.
Drug Details
- Generic Name
- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
- Brand Names
- ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve, Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night, Alka-Seltzer Plus Severe Cold Night PowerFast Fizz, Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz, Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve, ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve
- Application Number
- M012
- Sponsor
- Bayer HealthCare LLC.
- NDC Codes
- 7
- Dosage Forms
- KIT, TABLET, EFFERVESCENT
- Routes
- ORAL
- Active Ingredients
- ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
Indications and Usage
Uses Uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · runny nose · nasal congestion · sinus congestion and pressure · sneezing · sore throat · temporarily reduces fever
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. 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 ● diabetes ● thyroid disease ● glaucoma ● cough that is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis ● taking sedatives or tranquilizers When using When using this product ● do not exceed recommended dosage · may cause marked drowsiness ● alcohol, sedatives, and tranquilizers may increase the drowsiness effect ● avoid alcoholic drinks ● be careful when driving a motor vehicle or operating machinery ● excitability may occur, especially in children Stop use Stop use and ask a doctor if · an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better · pain, cough, or nasal congestion gets worse or lasts more than 7 days · fever gets worse or lasts more than 3 days · redness or swelling is present · new symptoms occur · cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. · ringing in the ears or a loss of hearing occurs · nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it 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.