Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 69676-0074 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens allergy |
||||
| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
||||
| Active Ingredients |
|
||||
| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1049906 | ||||
| Application Number | M013 | ||||
| Labeler Name | Genexa Inc. | ||||
| Packages |
|
||||
| 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 take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only with enclosed dose cup. Do not use with any other dosing device. adults and children 12 years of age and over 10 - 20 mL children 6 to under 12 years 5 - 10 mL children 2 to under 6 years do not use unless directed by a doctor children under 2 years do not use
| adults and children 12 years of age and over | 10 - 20 mL |
| children 6 to under 12 years | 5 - 10 mL |
| children 2 to under 6 years | do not use unless directed by a doctor |
| children under 2 years |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients organic agave syrup, natural citric extract, purified water
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 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.Childrens Allergy Diphenhydramine HCl AGAVE TEQUILANA JUICE WATER CITRUS FRUIT DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Golden Organic Agave Syrup Flavor
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.Children's Allergy Children's Genexa® MEDICINE MADE CLEAN Ages 6+ Allergy Diphenhydramine HCl Oral Solution 12.5 mg per 5 mL | Antihistamine Sneezing Itchy, Watery Eyes Itchy Throat or Nose Runny Nose Compare to active ingredient in Children’s Benadryl® Allergy Liquid Cherry* How we're different Made without: FD&C red no. 40, sodium benzoate, sucrose & more! Organic Agave Syrup Flavor Alcohol Free 4 FL OZ (118 mL) Dosing cup included 100A_Allergy_Childrens_Carton_R-20220214
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only with enclosed dose cup. Do not use with any other dosing device. adults and children 12 years of age and over 10 - 20 mL children 6 to under 12 years 5 - 10 mL children 2 to under 6 years do not use unless directed by a doctor children under 2 years do not use
| adults and children 12 years of age and over | 10 - 20 mL |
| children 6 to under 12 years | 5 - 10 mL |
| children 2 to under 6 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
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
*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Benadryl® Allergy Liquid Cherry. Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing. Patent Pending | Distributed by: Genexa Inc. Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients. NDC 69676-0074-9
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 glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland
Ask a 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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin
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. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-436-3921
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 breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20-25°C (68-77°F)
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 any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the 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 breastfeeding, 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. (1-800-222-1222)
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