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| Product NDC Code | 60687-267 | ||||
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| 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 | ||||
| Application Number | part341 | ||||
| Labeler Name | American Health Packaging | ||||
| 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 10 mL cup) Diphenhydramine HCl 25 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 find right dose on chart below take every 4 to 6 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over 1 cup (10 mL) to 2 cups (20 mL) children 6 to under 12 years 1/2 cup (5 mL) to 1 cup (10 mL) children under 6 years DO NOT USE
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.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.Siladryl Allergy Medicine Diphenhydramine Hydrochloride ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SACCHARIN SODIUM SODIUM CITRATE, UNSPECIFIED FORM SORBITOL WATER 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.Principal Display Panel Diphenhydramine Hydrochloride Liquid Antihistamine •Sugar Free • Alcohol Free FOR INSTITUTIONAL USE ONLY Store between 20° and 25°C (68° and 77°F). Protect from light. 8426769/1121F Diphenhydramine Hydrochloride Tray Label
Principal Display Panel – Cup - 25 mg per 10 mL/10 mL NDC 60687- 267 -42 Diphenhydramine Hydrochloride Liquid Antihistamine 25 mg / 10 mL Delivers 10 mL Sugar Free. Alcohol Free. See package Drug Facts insert for information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 0426769/0221 25 mg per 10 mL Diphenhydramine Hydrochloride Liquid Cup Label
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.Other information Each 10 mL cup contains: Sodium 28 mg. Store between 20° to 25°C (68° to 77°F). Protect from light. DO NOT USE IF SEAL IS BROKEN. This drug product is supplied in 10 mL unit dose cups as: 30 cups (3 x 10) NDC 60687-267-08 100 cups (10 x 10) NDC 60687-267-56
PACKAGING INFORMATION American Health Packaging unit dose cups contain drug product Siladryl Allergy (Diphenhydramine Hydrochloride) from Silarx Pharmaceuticals, Inc. as follows: (25 mg per 10 mL / 30 UD) NDC 60687-267-08packaged from NDC 54838-135 (25 mg per 10 mL / 100 UD) NDC 60687-267-56 packaged from NDC 54838-135 Distributed by: American Health Packaging Columbus, OH 43217 8426769/1121F
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