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| Product NDC Code | 10702-017 | ||||||||||
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| Drug Name | Chlorphen-12 |
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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, FILM COATED, EXTENDED RELEASE | ||||||||||
| RxCUI drug identifier | 1363288 | ||||||||||
| Application Number | ANDA040829 | ||||||||||
| Labeler Name | KVK-Tech, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Chlorpheniramine maleate 12 mg Antihistamine
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: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate
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 the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Purpose
Information about the drug product’s indications for use.PURPOSE Chlorpheniramine maleate 12 mg is used as an antihistamine. Manufactured by: KVK-Tech, Inc. Newtown, PA 18940 logo
Spl product data elements
Usually a list of ingredients in a drug product.Chlorphen-12 Chlorpheniramine Maleate CALCIUM SULFATE CARNAUBA WAX SILICON DIOXIDE SUCROSE D&C YELLOW NO. 10 FD&C BLUE NO. 2 GELATIN LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A METHYLPARABEN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL SODIUM BENZOATE SODIUM LAURETH SULFATE TITANIUM DIOXIDE TRIETHYL CITRATE FD&C YELLOW NO. 6 TALC CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE Chlorphen;12
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 - 24 Tablets Carton New Look. Same Trusted Ingredient. MADE IN USA NDC 10702-017-24 Chlorphen-12 Allergy Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat 3 in 1 Fast Acting Long Lasting Less Drowsy 24 Tablets Indoor & Outdoor Allergies 12-hour Extended-Release Tablets Chlorpheniramine Maleate 12 mg/Antihistamine 24 tab pic 1 24 tabs pic 2
Principal Display panel - 60 Tablets Container Label New Look. Same Trusted Ingredient. MADE IN USA NDC 10702-017-06 Chlorphen-12 Allergy Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat 3 in 1 Fast Acting Long Lasting Less Drowsy 60 Tablets Indoor & Outdoor Allergies 12-hour Extended-Release Tablets Chlorpheniramine Maleate 12 mg/Antihistamine container label - 60s
New Look. Same Trusted Ingredient. MADE IN USA NDC 10702-017-01 Chlorphen-12 Allergy Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat 3 in 1 Fast Acting Long Lasting Less Drowsy 100 Tablets Indoor & Outdoor Allergies 12-hour Extended-Release Tablets Chlorpheniramine Maleate 12 mg/Antihistamine container label - 100s
Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets New Look. Same Trusted Ingredient. MADE IN USA NDC 10702-017-04 NDC 10702-017-54 Chlorphen-12 Allergy Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat 3 in 1 Fast Acting Long Lasting Less Drowsy 4 Tablets in a sachet and a carton of 50 sachets Indoor & Outdoor Allergies 12-hour Extended-Release Tablets Chlorpheniramine Maleate 12 mg/Antihistamine 50 sachet carton 4 tablets sachet
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.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each tablet contains: calcium 28 mg store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) protect from excessive moisture
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 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 alchohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 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