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| Product NDC Code | 80513-722 | ||||
|---|---|---|---|---|---|
| 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 | Advanced Rx 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 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, or as directed by a doctor do not take more than 6 doses in 24 hours Adults and children 12 years and over: 1 or 2 caplets Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc
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 itchy 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE TALC D25
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.NDC 80513-722-06 Compare to Benadryl ® Allergy Ultratab ® active ingredient* ALLERGY RELIEF DIPHENHYDRAMINE HCl 25 mg ANTIHISTAMINE RELIEVES: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat 600 MINI TABLETS *This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ® Allergy Ultratab ® label
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.Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A. MADE IN THE USA
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 trouble urinating due to an enlarged prostate gland glaucoma 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 your 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 toll free 1-800-630-8895 Monday through Friday 9 AM - 5 PM EST.
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 beverages excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Each caplet contains: Calcium 23.52 mg store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
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 trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis ask your doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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