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| Product NDC Code | 70000-0584 | ||||
|---|---|---|---|---|---|
| Drug Name | Sleep-aid diphenhydramine hcl |
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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 | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1049909 | ||||
| Application Number | M010 | ||||
| Labeler Name | Cardinal Health 110, LLC. DBA Leader | ||||
| 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 softgel) 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 •take only one dose per day (24 hours) adults and children 12 years and over take 2 softgels at bedtime if needed or as directed by a doctor children under 12 years do not use
| adults and children 12 years and over | take 2 softgels 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 edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution
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 •for relief of occasional sleeplessness •reduces time to fall asleep if you have difficulty falling asleep
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.Sleep-Aid Diphenhydramine HCl Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED WATER SORBITOL SORBITAN oblong 779
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.Packaging Cardi-1
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.Drug Facts
LEADER ™ Non-Habit Forming Not for Treating Pain, Cold or Flu COMPARE TO VICKS ® ZZZQUIL ® NIGHTTIME SLEEP-AID LIQUICAPS ® active ingredient* 100% Money Back Guarantee *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil ® NIGHTTIME SLEEP-AID LiquiCaps ® . All LEADER TM Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Product of UAE Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING
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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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? 1-888-577-8033 Monday-Friday 8am-4pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other information •store at 20-25°C (68-77°F) •avoid excessive heat above 40°C (104°F) •protect from light
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 •for children under 12 years of age •with any other product containing diphenhydramine, even one used on skin •with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid When using this product •avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery. 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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