Sleep Aid
FDA Label NDC 59970-079

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies,llc for the product Sleep Aid (NDC 59970-079). 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, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Do Not Use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

avoid alcoholic beverages

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and older:
    • take 2 tablets at bedtime if needed or as directed by your doctor.

Other Information

  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive Ingredients

FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxide

Package Label

Vida Mia Sleep Aid Original Formula

Image Of Sleep-aid Carton (Sleepaid.nav)

Image Of Sleep-aid Carton (Sleepaid.nav)

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