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| Product NDC Code | 70692-022 | ||||
|---|---|---|---|---|---|
| Drug Name | Good remedies 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 | Strive Pharmaceuticals Inc. | ||||
| 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 doctor ■ do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 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 croscarmellose sodium, dicalcium phosphate, D&C red no. 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, 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 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.GOOD REMEDIES Allergy Relief Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE D&C RED NO. 27 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE S2
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.Packaging GOOD REMEDIES Allergy Relief 70692-022-06
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
Compare to the active ingredient of Benadryl ® Allergy Ultratabs ® * • Sneezing • Itchy, watery eyes • Runny nose • Itchy throat READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Benadryl ® Allergy Ultratabs ® TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA
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. Overdose warning: 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 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? 1-888-577-8033 Monday - Friday 8am - 4pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ each tablet contains: calcium 21 mg ■ store at room temperature between 20 - 25°C (68-77°F) ■ avoid excessive heat, cold and humidity ■ close cap tightly after 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 other products containing diphenhydramine, even ones 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 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. Overdose warning: 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 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