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| Product NDC Code | 51013-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Allergy relief |
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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, LIQUID FILLED | ||||
| RxCUI drug identifier | 1049909 | ||||
| Application Number | part341 | ||||
| Labeler Name | PuraCap Pharmaceutical LLC | ||||
| Packages |
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Overdosage of Allergy Relief
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each softgel) 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 take 1 to 2 softgels children 6 to under 12 years of age take 1 softgel children under 6 years of age do not take this product in children under 6 years of age
| adults and children 12 years of age and over | take 1 to 2 softgels |
| children 6 to under 12 years of age | take 1 softgel |
| children under 6 years of age | do not take this product in children under 6 years of age |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink
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 upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat • temporarily relieves these symptoms due to the common cold: o runny nose o 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.Allergy Relief Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL clear oblong PC4
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.PRINCIPAL DISPLAY PANEL - Carton Label PuraVation Allergy Relief Diphenhydramine HCl - 25 mg EACH 12 LIQUID-FILLED SOFTGELS NDC 51013-108-02 Carton 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.Drug Facts
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 glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis
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 or any other sleep aid
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.
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? Call toll free: 1-855-215-8180
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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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 avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15°-30° C (59°-86° F) in a dry place protect from heat, humidity, and light
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 glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
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