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| Product NDC Code | 69842-834 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Diphenhydramine hydrochloride |
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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 | TABLET, FILM COATED | ||||||
| RxCUI drug identifier | 1049630 | ||||||
| Application Number | part338 | ||||||
| Labeler Name | CVS Pharmacy, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of DIPHENHYDRAMINE HYDROCHLORIDE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each caplet) 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 ■ do not take more than directed ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor ■ children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin
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 for relief of occasional sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose Nighttime sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE LIGHT MINERAL OIL TITANIUM DIOXIDE TRIACETIN CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C BLUE NO. 1 MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE TALC CROSCARMELLOSE SODIUM CROSCARMELLOSE HYPROMELLOSES CPC;2824
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.CVSHealth Compare to the active ingredient in Simply Sleep®* Nighttime Sleep-Aid DIPHENHYDRAMINE HCl, 25 mg Nighttime sleep-aid • Safe, non-habit forming • Fall asleep fast, wake up rested • Does not contain pain reliever 500 MINI-CAPLETS CVS 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.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2018 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-34571
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 ■ 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 ■ in children under 12 years of age ■ 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each caplet contains: calcium 37 mg ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) ■ protect from moisture ■ use by expiration date on package
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? 1-800-231-4670
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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 ■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur ■ avoid alcoholic beverages
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 ■ in children under 12 years of age ■ 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 ■ 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 ■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur ■ avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 (1-800-222-1222) 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