Chlorpheniramine Maleate 4 mg/1
Chlorpheniramine Maleate · TABLET · PD-Rx Pharmaceuticals, Inc.
Chlorpheniramine Maleate is a tablet containing chlorpheniramine maleate at 4 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Chlorpheniramine Maleate
- Generic Name
- Chlorpheniramine Maleate
- NDC Code (Product)
55289-560- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 12/19/1992
Recall History
BLI International, Inc.
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Pharmatech LLC
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Pharma-Natural Inc.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Novartis Consumer Health
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Tris Pharma Inc.
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Novartis Consumer Health
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
The Harvard Drug Group
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses • temporarily relieves these symptoms due to a common cold or flu: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever
Dosage & Administration
Directions • do not use more than directed • take every 6 hours, while symptoms persist • Do not take more than 4 packets in 24 hours unless directed by a doctor • dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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. • in a child under 12 years of age • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. Ask a…
Frequently Asked Questions
What is Chlorpheniramine Maleate used for?
Chlorpheniramine Maleate contains Chlorpheniramine Maleate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Chlorpheniramine Maleate a controlled substance?
Chlorpheniramine Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Chlorpheniramine Maleate?
The generic name for Chlorpheniramine Maleate is Chlorpheniramine Maleate. There are 12 other brand versions of Chlorpheniramine Maleate.
What is the NDC code for Chlorpheniramine Maleate 4 mg/1?
The NDC (National Drug Code) for Chlorpheniramine Maleate 4 mg/1 is 55289-560, listed by PD-Rx Pharmaceuticals, Inc..
Other Chlorpheniramine Brands
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- Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz250 mg/167751-217
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- Allergy Relief4 mg/169842-194
- Allergy Relief4 mg/170677-1016
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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)