Chlorpheniramine maleate 4mg
Chlorpheniramine maleate 4mg is an FDA drug label for the active ingredient CHLORPHENIRAMINE MALEATE 4MG manufactured by Athlete's Needs, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20171114.
- Generic name
- CHLORPHENIRAMINE MALEATE 4MG
- Manufacturer
- Athlete's Needs, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 53185-277
- Application
- M012
- Label effective
- 20171114
About this product
Chlorpheniramine maleate 4mg is an FDA-registered drug product whose active ingredient is CHLORPHENIRAMINE MALEATE 4MG. It is labelled by Athlete's Needs, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 53185-277, application M012, label effective 20171114. 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.
What it is used for
Across FDA labelling, products containing CHLORPHENIRAMINE MALEATE 4MG are most often described in connection with: temporarily relieves, symptoms due, hay fever, upper respiratory, allergies sneezing, runny nose, itchy watery, eyes itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Dosage & Administration
Directions Adults and children 12 years and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age: ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours Children under 6 years of age: ask a doctor
Warnings
Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Recall and safety notices
1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1065-2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister | Glaxosmithkline Consumer Healthcare Holdings | Class II | Terminated | 20200401 |
Frequently asked questions
What is Chlorpheniramine maleate 4mg used for?
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Who makes Chlorpheniramine maleate 4mg?
Athlete's Needs, Inc. is the labeler of record for Chlorpheniramine maleate 4mg.
What form does Chlorpheniramine maleate 4mg 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 Chlorpheniramine maleate 4mg 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 Chlorpheniramine maleate 4mg been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.