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| Product NDC Code | 68788-8274 | ||||
|---|---|---|---|---|---|
| Drug Name | Diphenhydramine hcl |
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| Type | Generic | ||||
| 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 | SOLUTION | ||||
| RxCUI drug identifier | 1049906 | ||||
| Application Number | 341 | ||||
| Labeler Name | Preferred 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 (in each teaspoonful (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 • do not take more than 6 doses in 24 hours • mL = milliliter; FL OZ = fluid ounce • find right dose on chart below • take every 4 to 6 hours, or as directed by a doctor Age Dose adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, 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 upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o 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.Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP WATER SODIUM BENZOATE SODIUM CHLORIDE TRISODIUM CITRATE DIHYDRATE 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.Principal display panel MAJOR® NDC 68788-8274-1 Relabeled By: Preferred Pharmaceuticals Inc. Diphenhydramine HCl Oral Solution Antihistamine 12.5 mg/5 mL Institutional Dispensing only Cherry Flavored Alcohol Free TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV1019A01521 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Rev. 03/21 M-17 Relabeled By: Preferred Pharmaceuticals Inc. Diphenhydramine HCl Oral Solution 125mg/5mL
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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland
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.
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.
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? (800) 616-2471 Relabeled By: Preferred Pharmaceuticals Inc.
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 • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • use caution when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each teaspoonful (5 mL) contains: sodium 5 mg • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package
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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination 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 • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, 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.
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