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| Product NDC Code | 58809-116 | ||||
|---|---|---|---|---|---|
| Drug Name | Texaclear 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 | 1248354 | ||||
| Application Number | M010 | ||||
| Labeler Name | GM 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 Ingredients (in each 30 mL ) Diphenhydramine HCl 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 take only 1 dose per day (24-hour period). Do not exceed recommended dosage. only use with enclosed dose cup mL = mililiter Adults and children 12 years of age and over: 30 mL at bedtime if needed or as directed by a doctor Children under12 years of age: Do not use. Other Information each 30 mL contains: Sodium 15 mg store at room temperature 20-30ºC
| Adults and children 12 years of age and over: | 30 mL at bedtime if needed or as directed by a doctor |
| Children under12 years of age: | Do not use. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid anhydrous, glycerin, proplylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
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 the relief of occasional sleeplessnes 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.TexaClear Nighttime Sleep-Aid Diphenhydramine HCl GLYCERIN SODIUM BENZOATE SODIUM CITRATE ANHYDROUS CITRIC ACID SORBITOL SACCHARIN SODIUM ANHYDROUS WATER PROPYLENE GLYCOL 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.NDC 58809-116-08 TEXACLEAR NIGHTTIME SLEEP-AID 8 fl oz (237mL) PDP PDP
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 breathing problems 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
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.In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information each 30 mL contains: Sodium 15 mg store at room temperature 20-30ºC
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 1-888-535-0305 9 a.m. - 5 p.m. CST.
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 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 avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery
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 exceed recommended dosage. Do not use for children under 12 years of age 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