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.

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Peak Performance

Active ingredient (in each caplet)

Caffeine Anhydrous USP, 200 mg

Purpose

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

PEP-BACK  PEAK PERFORMANCE
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TAURINE (UNII: 1EQV5MLY3D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize15mm
FlavorImprint Code ALVA;1reverse
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-117-282 in 1 CARTON03/28/200703/31/2012
1NDC:52389-117-0114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34003/28/200703/31/2012
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2018
 
Alva-Amco Pharmacal Companies, Inc.