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| Product NDC Code | 0924-0056 | ||||
|---|---|---|---|---|---|
| Drug Name | Physicianscare allergy antihistamine |
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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 | ||||
| RxCUI drug identifier | 1049630 | ||||
| Application Number | part341 | ||||
| Labeler Name | Acme United Corporation | ||||
| 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 Ingredients (in each tablet) Diphenhydramine Hydochloride 25 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 Do not use more than directed Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide *may contain.
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 due to hay fever or other respiratory allergies runny nose sneezing itching nose or throat itchy-watery eyes temporarily relieves these symptoms due to the common cold runny nose sneezing
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.PhysiciansCare Allergy Antihistamine Diphenhydramine Hydrochloride CELLULOSE, MICROCRYSTALLINE CARNAUBA WAX POLYETHYLENE GLYCOL 2000 SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSCARMELLOSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE TITANIUM DIOXIDE MAGNESIUM STEARATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS LACTOSE POLYSORBATE 80 D&C RED NO. 27 Pink Oval 048;D PhysiciansCare Allergy Antihistamine Diphenhydramine Hydrochloride CELLULOSE, MICROCRYSTALLINE CARNAUBA WAX POLYETHYLENE GLYCOL 2000 SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSCARMELLOSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE TITANIUM DIOXIDE MAGNESIUM STEARATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS LACTOSE POLYSORBATE 80 D&C RED NO. 27 Pink Oval 061;T
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.BOX16790056-revC.jpg Carton 167
Box18490036-revC.jpg Carton184
PhysiciansCare Allergy Antihistamine: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information each caplet may contain: calium 25mg store at room temperature 59°-86°F (15°-30°C) protect from light use by expiration date on packet tamper-evident sealed packets do not use any opened or torn packets
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, contact a physician or poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-835-2263
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 Do Not Use to make a child sleepy with any other product containing diphenhydramine, even one that is used on the skin. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficuly in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product * marked drowsiness may occur and avoid alcoholic beverages * alcohol, sedatives and tranquilizers may increase the drowsiness effect * use caution when driving a motor vehicle or operating machinery * 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