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| Product NDC Code | 66267-977 | ||||
|---|---|---|---|---|---|
| Drug Name | Siladryl allergy medicine |
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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, 1094393 |
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| Application Number | part341 | ||||
| Labeler Name | NuCare Pharmaceuticals,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.Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))
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 repeat dose every 4 to 6 hours do not take more than 6 doses in any 24-hour period Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. adults and children 12 years and over 2 to 4 teaspoonfuls (TSP) children 6 to under 12 years 1 to 2 teaspoonfuls (TSP) children under 6 years DO NOT USE Other information Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).
| adults and children 12 years and over | 2 to 4 teaspoonfuls (TSP) |
| children 6 to under 12 years | 1 to 2 teaspoonfuls (TSP) |
| children under 6 years | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, 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.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.Siladryl Allergy Medicine diphenhydramine hydrochloride ANHYDROUS CITRIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SACCHARIN SODIUM SODIUM CITRATE SORBITOL WATER D&C RED NO. 33 FD&C RED NO. 40 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE black cherry
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.PDP
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.Questions 1-844-834-0530 Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512 10-1043 Rev. 04/18
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 trouble urinating due to an enlarged prostate gland 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 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 right away (1-800-222-1222).
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 a child sleepy with any other product containing diphenhydramine, even one used on skin.
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