Sleep Aid Tablet
FDA Label NDC 73581-205

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Sleep Aid (NDC 73581-205). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Doxylamine Succinate 25 mg

Purpose

Night sleep-aid

Uses

Helps to reduce difficulty in falling asleep

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.

Otc - Keep Out Of Reach Of Children

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]

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

Other Information

  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive Ingredients

dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

call toll-free 1-866-933-6337

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