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| Product NDC Code | 76281-505 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens allergy |
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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 | AptaPharma 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.Drug Facts Active ingredient (in each 5 mL teaspoon) 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 ■ if needed, take every 4-6 hours■ do not take more than 6 doses in 24 hours Children under 4 years of age: do not use Children 4 to under 6 years of age: do not use unless directed by a doctor Children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)
| Children under 4 years of age: | do not use |
| Children 4 to under 6 years of age: | do not use unless directed by a doctor |
| Children 6 to under 12 years of age: | 1 to 2 teaspoonfuls (12.5 mg to 25 mg) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
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 respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■ temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose
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.Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SUCROSE
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.Product Label AP SAFE NDC 72681-505-24 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ® ALLERGY LIQUID* Children's Allergy Relief DIPHENHYDRAMINE HCl Liquid Antihistamine Relieves: Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat • Alcohol-Free 4 FL OZ (118 mL) Cherry Flavor DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING 2 1013430 3/20 *This product is not manufactured or distributed by McNeil PPC, Inc., distributor of Benadryl ® Allergy liquid. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 AP-BX-03 Carton Bottle res 505-24 Box 505-24 Btl
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 ■ glaucoma ■ abreathing problem such as 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 a doctor or pharmacist before use if the child is 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 right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Keep carton for full directions for use ■ each teaspoonful contains: sodium 10 mg ■ store at 20° - 25° C(68° - 77° F) ■ dosage cup provided
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 weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.
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 ■ excitability may occur, especially in children ■ sedatives and tranquilizers may increase drowsiness
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
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