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Drugs and Health Products

Monograph: Caffeine

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Date: 2008-01-02


Caffeine (USP 2008a)

Proper Name(s)

1,3,7-trimethylxanthine ( USP 2007 )

Common Name(s)

Caffeine ( USP 2007 , IOM 2003 )

Source Material

Route Of Administration

Oral ( Higdon and Frei 2006 )

Dosage Form(s)

Only allowable pharmaceutical dosage forms: tablets, capsules and strips. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:



Mild diuretic
100 - 200 Milligrams per single dose , not to exceed 800 Milligrams per day

Directions For Use: Every 3 - 4 hours, as needed

Promotion of alertness and wakefulness, and enhancement of cognitive performance
100 - 200 Milligrams per single dose , not to exceed 1000 Milligrams per day

Directions For Use: Every 3 - 4 hours, as needed

Relief of fatigue, promotion of endurance, and enhancement of motor performance
100 - 200 Milligrams per single dose , not to exceed 1000 Milligrams per day

Directions For Use: Every 3 - 4 hours, as needed

Duration of use

For occasional use only  (Higdon and Frei 2006, Juliano and Griffiths 2004, Evans and Griffiths 1999)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

No statement is required

Known Adverse Reaction(s):
  • Hypersensitivity/allergy is known to occur, in which case, discontinue use  (Infante et al. 2003, Hinrichs et al. 2002)
  • Doses greater than or equal to 601 Milligrams per day:
    Caffeine may cause anxiety, tachycardia (rapid heart rate), palpitations, insomnia, restlessness, nervousness, tremor and headache  (IOM 2001, Zhang 2001, Sawynok 1995)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.


  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

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