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| Product NDC Code | 71594-708 | ||||
|---|---|---|---|---|---|
| Drug Name | Firstcare allergy relief diphenhydramine hci, 25 mg antihistamine |
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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 | BAR, CHEWABLE | ||||
| Application Number | M012 | ||||
| Labeler Name | USpharma Ltd | ||||
| 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 piece) 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 times in 24 hour Age (yr) Dose (Piece) Adults and children 12 years and over 1 to 2 Pieces (25 mg to 50 mg) Children 6 to 11 years 1 Piece (25 mg) Children under 6 years Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
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 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.FIRSTCARE ALLERGY RELIEF Diphenhydramine HCI, 25 mg Antihistamine Diphenhydramine HCl FD&C RED NO. 40 CORN SYRUP ACACIA HYDROXYPROPYL BETADEX GLYCERYL MONO AND DIPALMITOSTEARATE MALTITOL NEOTAME POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER CARRAGEENAN SODIUM CHLORIDE STARCH, CORN SUCRALOSE SUCROSE TRISODIUM CITRATE DIHYDRATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Light pink to red pink Mixed Berry
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-25 mg Bottle label FIRSTCARE NDC 71594-708-08 ***MADE IN USA*** Patent Pending ALLERGY RELIEF Diphenhydramine HCl 25 mg Antihistamine Gummy Bite Mixed Berry Flavor Relief of: Sneezing Runny nose Itchy, Watery eyes Itchy Throat 20 PIECES Principal display Panel-25 mg Bottle 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.Other information each piece: contains sodium 9 mg . low sodium store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.
Questions or comments? Call 1-800-227-6151
USpharma 13900 NW 57th Court, Miami Lakes, FL 33014 1-800-227-6151 www.uspharmaltd.com
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
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.
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 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 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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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