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| Product NDC Code | 54738-103 | ||||||||
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| Drug Name | Anti allergy |
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| Type | Brand | ||||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET | ||||||||
| RxCUI drug identifier | 1363309 | ||||||||
| Application Number | part341 | ||||||||
| Labeler Name | Richmond Pharmaceuticals, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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[/S] Adults & 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 ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours children under 6 years do not use
| Adults & 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 ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours |
| children under 6 years | |
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, silicon dioxide, starch
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 itchy nose or throat sneezing 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.Anti Allergy Chlorpheniramine Maleate CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SILICON DIOXIDE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE light yellow 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.PRINCIPAL DISPLAY PANEL Chlorpheniramine Maleate 4 mg Antihistamine NDC: 54738-103-01 - 100 CPM tablets NDC: 54738-103-03 - 1000 CPM tablets NDC: 54738-103-14 - 24 CPM tablets IMG_4672
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.Other Information each tablet contains: calcium 40 mg store between 15°-30°C (59°-86°F) protect from moisture
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 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED
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 an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating a machine excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use.
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