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| Product NDC Code | 55910-690 | ||||
|---|---|---|---|---|---|
| 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 | part336 | ||||
| Labeler Name | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ||||
| 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 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 more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 tablets children 6 to under 12 years of age take 1 tablet children under 6 years of age do not use this product in children under 6
| adults and children 12 years of age and over | take 1 to 2 tablets |
| children 6 to under 12 years of age | take 1 tablet |
| children under 6 years of age | do not use this product in children under 6 |
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, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol*, purified water*, talc*, titanium dioxide *contains one or more of these ingredients
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 of 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 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES EGG PHOSPHOLIPIDS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED WATER TALC TITANIUM DIOXIDE T061;V25;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.Principal Display Panel Compare to the active ingredient in Benadryl® Allergy** Allergy Relief Diphenhydramine HCl, 25 mg Antihistamine Relieves: sneezing itchy throat runny nose itchy, watery eyes Tablets **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor Benadryl® Allergy. 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 GOODLETSVILLE, TN 37072
Product Label DOLLAR GENERAL Allergy Relief Diphenhydramine HCI 25 mg
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. 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 each tablet contains : calcium 25mg store between 15-25°C (68-77°F) protect from light and moisture
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 1-888-309-9030
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 operating machinery or driving a motor vehicle excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of 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 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 operating machinery or driving a motor vehicle excitability may occur, especially in children If pregnant of 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