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| Product NDC Code | 71598-120 | ||||
|---|---|---|---|---|---|
| Drug Name | Instarelief nighttime sleep aid |
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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 | 2671699 | ||||
| Application Number | M010 | ||||
| Labeler Name | DXM Pharmacuetical, 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 3mL) (one dose) Diphenhydramine HCI, 50 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 only use this product according to these directions or as directed by a doctor do not exceed 1 dose (3 mL) (50 mg) in any24-hour period measure only 3 mL with dosing syringe provided keep dosing syringe with product mL = milliliter - fl oz = fluid ounce age dose adults and children 12 years and over 3mL at bedtime children under 12 years do not use
| adults and children 12 years and over | |
| children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, 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 For relief of occasional sleeplessness. Helps to reduce difficulty falling asleep. Reduces time to fall asleep. Warnings
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.InstaRelief Nighttime Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE STEVIA LEAF SUCRALOSE SUCROSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE
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.Product label image description
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 TAMPER EVIDENT: Do not use if seal on the bottle is broken. store at 20-25°C (68-77°F). Do not refrigerate.
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? Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.
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.Warning Do not use for children under 12 years of age, or with any other product containing diphenhydramine, even one used on skin. Do not take this product, unless directed by a doctor if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma, or difficulty in urination due to enlargement of the prostate gland. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a doctor before use. 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)
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