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Alva-Amco Pharmacal Companies, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Caffeine Anhydrous USP 200 mg.....................................Stimulant

Pep-Back Uses


Warnings


Ask a 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

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, 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

  • 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.  This product is not intended as a substitute for proper sleep, nutrition or athletic conditioning nor intended to improve athletic ability.  When taking this or any other drug consult a doctor before engaging in any strenuous physical activity.

Pep-Back Other information

  • Calcium content:  40 mg/caplet
  • Identification:  Red colored, oval shaped caplet bearing the identifying mark "ALVA" plus a "1" on the caplet's reverse side.
  • **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.
  • Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredients

Acacia, calcium carbonate, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, starch, stearic acid, taurine, titanium dioxide and triacetin.

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:52389-117
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAFFEINE 200 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
CALCIUM CARBONATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
hypromellose
magnesium silicate
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
Mineral Oil
STARCH, CORN
STEARIC ACID
TAURINE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
red 15 mm ALVA;1reverse OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52389-117-01 14 in 1 BLISTER PACK
2 NDC:52389-117-28 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part340 2007-03-28


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Be sure to consult your doctor before taking any medication!
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