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Product NDC Code | 55910-222 | ||||
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Drug Name | Allergy relief dye free |
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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 | M012 | ||||
Labeler Name | Dolgencorp, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 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 swallow whole; do not crush, chew or dissolve 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 use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, 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: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose
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 Dye Free Diphenhydramine HCl GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 611
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 Compare to the active ingredient of Benadryl® Dye-Free LIQUI-GELS®* Allergy Relief Diphenhydramine HCl 25 mg/Antihistamine Dye-Free temporarily Relieves: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Softgels *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 image description
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 an 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.
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 with any other product containing diphenhydramine, even one used on skin to make a child sleepy
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 between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat. Protect from light, heat, humidity
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 1-888-333-9792
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.
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 with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have glaucoma trouble urinating due to an 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. 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 If pregnant or 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)
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