Topcare Stay Awake Maximum Strength

CAFFEINE ORAL HUMAN OTC DRUG

Topcare Stay Awake Maximum Strength is an FDA drug label for the active ingredient CAFFEINE manufactured by TopCo Associates, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210428.

Generic name
CAFFEINE
Manufacturer
TopCo Associates, LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
76162-002
Application
M011
Label effective
20210428

Active ingredients

Active ingredient(s) Caffeine 200mg

Indications & Usage

Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage & Administration

Directions Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours Children under 12 years of age: do not use

Contraindications

Not available.

Warnings

Warnings For occasional use only. Do not use in children under 12 years of age as a substitute for sleep When using this product limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and ocassionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Adverse Reactions

Not available.

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