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Product NDC Code | 83324-016 | ||||
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Drug Name | Quality choice dye free cherry childrens 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 | LIQUID | ||||
RxCUI drug identifier | 1049906 | ||||
Application Number | part341 | ||||
Labeler Name | Chain Drug Marketing Association Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT(S) 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 do not take more than 6 doses in 24 hours AGE(yr) DOSE(mL or tsp) children under 2 years do not use children under 6 years ask a doctor children 6 to 11 years 1 to 2 tsp (5 mL to 10 mL)
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children under 2 years | do not use |
children under 6 years | ask a doctor |
children 6 to 11 years | 1 to 2 tsp (5 mL to 10 mL) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, 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.USE(S) 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
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.Quality Choice Dye Free Cherry Childrens Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID GLYCERIN SACCHARIN SODIUM WATER SODIUM BENZOATE 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 NDC 83324-016-04 QC ® QUALITY CHOICE *Compare to the Active Ingredient in Children's Benadryl ® Dye Free Allergy Liquid Dye Free Children's Allergy Relief Antihistamine Diphenhydramine HCl 12.5 mg/5ml Relieves : Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat CHERRY FLAVOR 4FL OZ(120 mL) qch-549-label-4oz.jpg qch-549-carton-4oz.jpg
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 CHILD HAS glaucoma a breathing problem such as emphysema or chronic bronchitis 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 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION each tsp contains : sodium 5 mg dosing cup provided store at 68°-77°F
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 alcohol, sedatives and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur, especially in children
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 .
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