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| Product NDC Code | 0536-1010 | ||||
|---|---|---|---|---|---|
| Drug Name | Diphenhist |
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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 | CAPSULE | ||||
| RxCUI drug identifier | 1049909, 1092447 |
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| Application Number | M012 | ||||
| Labeler Name | Rugby Laboratories | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Diphenhist
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each banded capsule) 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 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.
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 of hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat 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.Diphenhist Diphenhydramine HCl STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE ANHYDROUS LACTOSE Half pink and half clear with white powder inside CPC;835
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.Rugby NDC 0536-1010-01 Diphenhist Diphenhydramine HCl USP, 25 mg Antihistamine For the temporary relief of the Symptoms of Upper Respiratory Allergies & Hay Fever 100 Banded Capsules 0835-rugby label
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.DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 www.rugbylaboratories.com
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 glaucoma 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 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 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at controlled room temperature 15°-30°C (59°-86°F) in a dry place protect from moisture contains lactose
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? 1-800-645-2158
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 alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when operating machinery or driving a motor vehicle excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of 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 Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when operating machinery or driving a motor vehicle excitability may occur, especially in children If pregnant of breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222 In case of overdose, get medical help or contact a 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