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| Product NDC Code | 67091-381 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Complete 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 | part341 | ||||||
| Labeler Name | WinCo Foods 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 ingredients (in each caplet) 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 caplets children 6 to under 12 years of age: 1 caplet 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 carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, 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 • itchy, watery eyes • sneezing • itchy 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.Complete Allergy Relief Diphenhydramine HCl 25mg CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE POLYSORBATE 80 TITANIUM DIOXIDE MAGNESIUM STEARATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYPROMELLOSES T;061
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.160R-Winco-Allergy-Relief-bottle-label-100s 160R-Winco-Allergy-Relief-carton-label-100s 160R-Winco-Allergy-Relief-carton-label-24s
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
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • each caplet contains: calcium 25 mg • protect from light • store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-824-1706 Monday - Friday 9 am-4pm MST
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 • excitability may occur, especially in children • 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.
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 When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • be careful when driving a motor vehicle or operating machinery 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.
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