Pep-Back Peak Performance

Dosage form: tablet, film coated
Ingredients: Caffeine 200mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-117

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.

Drug Facts

Active ingredient (in each caplet)

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

UsesHelps 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

PEP-BACK  PEAK PERFORMANCE
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Caffeine (Caffeine) Caffeine200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVALSize15mm
FlavorImprint CodeALVA;1reverse
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-117-282 BLISTER PACK (BLISTER PACK) in 1 CARTON
1NDC:52389-117-0114 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34003/28/2007
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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