Pep-Back Peak Performance: Package Insert and Label Information

PEP-BACK PEAK PERFORMANCE- caffeine tablet, film coated
Alva-Amco Pharmacal Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each caplet)

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

Uses

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

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
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, 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.

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

PepBack Peak Performance PDP
(click image for full-size original)

PEP-BACK PEAK PERFORMANCE
caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Caffeine (Caffeine) 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 red Score no score
Shape OVAL Size 15mm
Flavor Imprint Code ALVA;1reverse
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52389-117-28 2 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK (52389-117-01)
1 NDC:52389-117-01 14 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (52389-117-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 03/28/2007
Labeler — Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010 Alva-Amco Pharmacal Companies, Inc.

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