Stay Awake Tablet, Coated
FDA Label NDC 83059-0008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Stay Awake (NDC 83059-0008). 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 other, active ingredient (in each liquid-filled capsule), purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Active Ingredient (In Each Liquid-Filled Capsule)

Caffeine 200 mg

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Otc - Do Not Use

Do not use

  • as a substitute for sleep. This product is intended for occasional use only.
  • in children under 12 years of age

Otc - When Using

When using this productlimit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Otc - Stop Use

Stop use and ask a doctorif fatigue or drowsiness persists or continues to recur.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask 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 (1-800-222-1222) right away.

Directions

adults and children 12 years and over:

  • take 1 tablet not more often than every 3 to 4 hours

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

  • each tablet contains: calcium 60 mg
  • store in a dry place at 15° – 30°C (59° – 86°F)
  • do not use if imprinted seal under cap is broken or missing

    • FD&C yellow # 6, magnesium stearate, maize starch, microcrystalline cellulose, povidone, stearic acid, Sodium Starch Glycolate, talc

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Stay Awake

Caffeine 200 mg/ Alertness Aid

  • Caffeine for mental alertness
  • Equal to about a cup of coffee

    • Carton

    Label

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