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Chlorpheniramine maleate 4 mg - Medication Information

Product NDC Code 72789-134
Drug Name

Chlorpheniramine maleate 4 mg

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Chlorpheniramine maleate 4 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 1363309
Application Number M012
Labeler Name PD-Rx Pharmaceuticals, Inc.
Packages
Package NDC Code Description
72789-134-24 24 tablet in 1 bottle, plastic (72789-134-24)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours children under 6 years do not use
adults and children 12 years and overtake 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes

Purpose

Information about the drug product’s indications for use.
Purpose Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Chlorpheniramine Maleate 4 mg Chlorpheniramine Maleate D&C YELLOW NO. 10 CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, PREGELATINIZED CORN SILICON DIOXIDE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE AP;016

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Chlorpheniramine Maleate 4mg ANTIHISTAMINE 72789134 Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other information each tablet contains: calsium 40 mg store at 15°-30°C (59°-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING * Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton® Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580 www.reliable1labs.com

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

How supplied

Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.
16 HOW SUPPLIED Chlorpheniramine MaleateTablets are available as follows: 4 mg: Yellow, round, scored tablet, debossed "heart”. Available in bottles of 24 tablets (NDC 72789-134-24)

General precautions

Information about any special care to be exercised for safe and effective use of the drug.
When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Drug Facts continued on back of label

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Ask a doctor before use if you have glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API