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Alva-Amco Pharmacal Companies, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Caffeine anhydrous, 200 mg.........................................Stimulant

Use

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Warnings


Ask doctor before use if

  • taking any other medications
  • under 18 years of age.  Do not give to 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
  • occasional rapid heart beat.

The recommended dose of this product contains about as much caffeine as two cups 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 breastfeeding,

Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.

Directions

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults:  One caplet (200 mg) not more often than every 3 to 4 hours.
  • Recommended for use by normally healthy adults only.

Pep-Back Other information

  • Calcium content: 180 mg/caplet.
  • Identification:  Light green colored, oval shaped caplet bearing the identifying mark "ALVA".
  • **Contents sealed in clear plastic blisters with a foil backing.  Do not use if seal appears broken or if product contents do not match product description.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Calcium carbonate, calcium sulfate, corn starch, DC Yellow No. 10 Lake, FDC Blue No. 1 Lake, FDC Blue No. 2 Lake*, FDC Red No. 40 Lake*, hypromellose, magnesium silicate*, magnesium stearate, mineral oil*, polyehtylene glycol, polysorbate 80*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, titanium dioxide* and vanillin.  *Contains one or more of these ingredients.

Questions?  1-800-792-2582

Pep-Back

Pep-Back

Caffeine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52389-154
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAFFEINE 200 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
CALCIUM SULFATE DIHYDRATE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
hypromellose
magnesium silicate
MAGNESIUM STEARATE
Mineral Oil
POLYETHYLENE GLYCOL 600
polysorbate 80
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
titanium dioxide
VANILLIN

Product Characteristics

Color Size Imprint Code Shape
green 15 mm ALVA OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52389-154-09 9 in 1 BLISTER PACK
2 NDC:52389-154-12 12 in 1 BLISTER PACK
3 NDC:52389-154-36 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part340 1993-04-08


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