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| Product NDC Code | 82706-005 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Axim allergy |
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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 | VIVUNT LLC | ||||||
| Packages |
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Overdosage of Axim Allergy
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose Warning In case of overdose, get medical help or contact a poison control center immediately.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Antihistamine
| Diphenhydramine HCl 25 mg | Antihistamine |
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, or as directed by a doctor Do not take more than 12 Softgels in 24 hours for Adults and do not take more than 6 Softgels for children 6 to 12 years of age in 24 hours. adults and children 12 years and over 1 or 2 Softgels children 6 to under 12 years 1 Softgel children under 6 years do not use
| adults and children 12 years and over | 1 or 2 Softgels |
| children 6 to under 12 years | 1 Softgel |
| children under 6 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, 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 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.Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Antihistamine
| Diphenhydramine HCl 25 mg | Antihistamine |
Spl product data elements
Usually a list of ingredients in a drug product.Axim Allergy Diphenhydramine Hydrochloride PROPYLPARABEN GELATIN METHYLPARABEN WATER GLYCERIN SORBITOL POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE axim Transparent
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 24 Compare to Benadryl® Allergy Liqui-Gels® active ingredients* NDC 82706-005-01 Antihistamine Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat DYE-FREE Diphenhydramine HCl 24 SOFTGELS** **Liquid-filled capsules Axim Allergy
PRINCIPAL DISPLAY PANEL 6 Compare to Benadryl® Allergy Liqui-Gels® active ingredients* NDC 82706-005-02 Antihistamine Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat DYE-FREE Diphenhydramine HCl 6 SOFTGELS** **Liquid-filled capsules Allergy
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 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.
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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
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 driving a motor vehicle or operating machinery excitability may occur, especially in children Keep out of reach of children. If pregnant or breast-feeding ask a health professional before use. Overdose Warning In case of overdose, get medical help or contact a poison control center immediately.
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