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| Product NDC Code | 72090-021 | ||||||
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| 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 | TABLET | ||||||
| RxCUI drug identifier | 1049630 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Pioneer Life Sciences, LLC | ||||||
| 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 tablet) Diphenhydramine Hcl 25mg
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 6 times in 24 hours. ■ Adults and children 12 years and over: 1 to 2 tablets ■ Children 6 years to under 12 years: 1 tablet ■ Children under 6 years: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry-II 85G540006 Pink
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.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Allergy Relief Diphenhydramine HCl 25 mg DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE LECITHIN, SOYBEAN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED D&C RED NO. 27 ALUMINUM LAKE S4
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.PL0060-Rev 00 Diphenhydramine-600ct-Elysium 02.02.24
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 troble 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.
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Each tablet contains: ■Calcium 24mg ■Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.
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 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com
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 ■ 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: to make a child sleepy with any other product containing diphenhydramine, even one used on skin
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