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| Product NDC Code | 55621-005 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Theraplus plus |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1372298 | ||||||
| Application Number | M015 | ||||||
| Labeler Name | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ||||||
| 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 gram) Mineral oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%
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 of age and older for topical use: -clean the affected area, and oat or dab dry before applying ointment -apply to the affected area up to 4 times daily, especially after each bowel movement for intrarectal use: -attach included applicator to tube -lubricate applicator tip and gently insert into rectum -thoroughly clean applicator after each use, and replace cover children under 12 years of age: ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients
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 -helps relieve the local itching and discomfort associated with hemorrhoids -temporarily shrinks hemorrhoid tissue and relieves burning -temporarily provides a coating for relief of anorectal discomforts -temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Purpose
Information about the drug product’s indications for use.Purpose Protectant Protectant Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.TheraPlus Plus Phenylephrine HCI YELLOW WAX BENZOIC ACID CETYL ALCOHOL GLYCERIN LAURETH-23 METHYLPARABEN PROPYLPARABEN STEARYL ALCOHOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM
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.copy of label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have -heart disease -high blood pressure -thyroid disease -diabetes -trouble urinating due to an enlarged prostate gland
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 -presently taking a prescription drug for high blood pressure
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.. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if -bleeding occurs -condition worsens or does not improve within 7 days -introduction of the applicator into the rectum causes additional pain
Pregnancy or breast feeding
Pregnancy or Breast feeding, ask a health professional before use If pregnant or breast-feeding
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 For external and/or intrarectal use only
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