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Caffeine

AAA Pharmaceutical, Inc.

Caffeine Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

Do not use in children under 12 years of age

When using this product limit 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.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

For occasional use only. Not intended as a substitute for sleep.

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.

Directions

  • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours

Caffeine Other information

  • each tablet contains: calcium 80 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dibasic calcium phosphate, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 16 Tablet Carton

RESTORE u

NDC 57344-020-01

COMPARE TO THE ACTIVE
INGREDIENT IN VIVARIN®

Stay Awake

ALERTNESS AID
Caffeine

16 TABLETS - 200 mg each

Caffeine

Caffeine

CAFFEINE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-020
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAFFEINE 200 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
cellulose, microcrystalline
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
YELLOW 11 mm LL64;57344 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 8 in 1 BLISTER PACK
4 NDC:57344-020-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part340 2012-12-15


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Be sure to consult your doctor before taking any medication!
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