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| Product NDC Code | 63868-128 | ||||
|---|---|---|---|---|---|
| Drug Name | Dye free allergy childrens |
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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 | LIQUID | ||||
| RxCUI drug identifier | 1049906 | ||||
| Application Number | M012 | ||||
| Labeler Name | QUALITY CHOICE (Chain Drug Marketing Association) | ||||
| 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 5 mL) Diphenhydramine HCl 12.5 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 do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product find the right dose on the chart below age (yr) dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
| age (yr) | dose (mL) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol
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: sneezing runny nose itchy, watery eyes itching of the nose or throat
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.Dye Free Allergy childrens Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM SORBITOL
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 Children's Benadryl® Allergy Dye-Free Children's Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution Liquid Medication Relieves Runny Nose | Sneezing | Itchy, Watery Eyes | Itchy Throat For Ages 6 to 11 Years Alcohol-Free Dye-Free Bubble Gum Flavored FL OZ (mL) *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . Distributed by C.D.M.A., Inc,© 43157 W.Nine Mile Novi, MI 48376-0995 www.qualitychoice.com
Package Label QUALITY CHOICE Dye-Free Children's Allergy Diphenhydramine HCI 12.5 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 the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet
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 the child is 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 (1-800-222-1222) right away.
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 1-248-449-9300 Monday-Friday 9AM-5PM 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 sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
Storage and handling
Information about safe storage and handling of the drug product.Other information each 5 mL contains : sodium 8 mg store between 20-25°C (68-77°F). Do not refrigerate. Protect from light. Store in outer carton until contents are used.
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 the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children 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