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| Product NDC Code | 73581-205 | ||||
|---|---|---|---|---|---|
| Drug Name | Sleep aid 25mg |
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| Type | Brand | ||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1101446 | ||||
| Application Number | ANDA040564 | ||||
| Labeler Name | YYBA CORP | ||||
| 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 tablet) Doxylamine Succinate 25 mg Purpose Night sleep-aid
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 adults and children 12 years and older: take one tablet 30 minutes before going to bed; take one daily 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 dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
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 Helps to reduce difficulty in falling asleep
Purpose
Information about the drug product’s indications for use.Purpose Night sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.SLEEP AID 25mg DOXYLAMINE SUCCINATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A DOXYLAMINE SUCCINATE DOXYLAMINE 44;386
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.01b LBL_Sleep Aid Tablets_25mg.jpg 01b DF1_Sleep Aid Tablets_25mg.jpg 01b DF2_Sleep Aid Tablets_25mg.jpg
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 [1-800-222-1222]
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20° and 25°C (68° and 77°F) protect from excessive moisture
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call toll-free 1-866-933-6337
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 Ask a doctor before use if you have. a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate glad glucoma Ask a doctor or pharmacist before use if you are taking any other drugs. When usinf this product avoid alcohol beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuosly for more than two weeks. Insomnia may be s symptom of serious underlying medical illness. If pregnant of breast-feeding, as a health professional before use.
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