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| Product NDC Code | 47682-167 | ||||||||
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| Drug Name | Medique diphen |
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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 | Unifirst First Aid 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 ingredient (in each caplet) Diphenhydramine HCl 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 take every 4-6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Adults and children: (12 years and over) 1 to 2 caplets Children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
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 of the 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.Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 27 DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE pink OVAL 061;T Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 27 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE pink OVAL 048;D
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.184R Medique Diphen Label Collect MediBucks See inside flap for more details Medique® Diphen Hay Fever / Allergies Fiebre del Heno / Alergias This Package is for Households without Young Children. Este Paquete Es Para Hogares Sin Ninos Pequenos. Antihistamine • Diphenhydramine HCl 25 mg Antihistaminico • Hidrocloruro de Difenhidramina 25mg 200 Caplets (200 x 1) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias 184R
Medique 167 Diphen Principal Display Panel Collect MediBucks See inside flap for more details Medique® Diphen Hay Fever / Allergies Fiebre del Heno / Alergias This Package is for Households without Young Children. Este Paquete Es Para Hogares Sin Ninos Pequenos. Antihistamine • Diphenhydramine HCl 25 mg Antihistaminico • Hidrocloruro de Difenhidramina 25mg 200 Caplets (200 x 1) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias Diphen
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.Drug Facts
Other information store at room temperature 68º-77ºF (20º-25ºC) protect from light tamper-evident sealed packets do not use any opened or torn packets
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 ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin.
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 right away (1-800-222-1222).
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? 1-800- 634-7680
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 marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged 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 avoid alcohol beverages alcohol, sedatives and tranquilizers may increase drowsiness 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. Keep out of the reach of children . In case of overdose, contact a physician or poison control center right away (1-800-222-1222).
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