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| Product NDC Code | 49483-242 | ||||||||||
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| Drug Name | Allergy time |
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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 | Time Cap Labs 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
| 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 - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age - 1/2 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 - do not use
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
| anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid. |
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: runny nose, sneezing, itching of the nose or throat, itch, watery eyes
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Purpose
Information about the drug product’s indications for use.Purpose: Antihistamine
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Spl product data elements
Usually a list of ingredients in a drug product.Allergy Time Chlorpheniramine Maleate ANHYDROUS LACTOSE SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE TCL242
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.100 CT LABEL
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.
| 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. |
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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 operating machinery
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Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
| If pregnant or breast-feeding ask a health professional before use. |
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; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland
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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