Good Sense Sleep Aid Ultra Tablet, Coated
FDA Label NDC 0113-4032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L. Perrigo Company for the product Good Sense Sleep Aid Ultra (NDC 0113-4032). 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)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

  • helps to reduce difficulty in falling asleep

Do Not Use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking

  • a sedative or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When Using This Product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • take only at bedtime

Stop Use And Ask A Doctor If

  • sleeplessness persists continuously for more than two 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • keep carton. It contains important information.

Inactive Ingredients

anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

GOODSENSE®

Nighttime

Sleep Aid Ultra

Doxylamine Succinate Tablets 25 mg

Actual Size

Nighttime Sleep-Aid

1 Tablet Per Dose

Berry Flavor

Clinically Tested, Proven Effective

24 Tablets

Compare to active ingredient of Vicks® ZzzQuil® Ultra Tablets

Goodsense-sleep-aid-berry-carton-image.jpg (Goodsense Sleep Aid Berry Carton Image)

Goodsense-sleep-aid-berry-carton-image.jpg (Goodsense Sleep Aid Berry Carton Image)

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