Pep-Back Ultra

Dosage form: tablet, film coated
Ingredients: Caffeine 200mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-154

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

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, 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.

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  ULTRA
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Caffeine (Caffeine) Caffeine200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint CodeALVA
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-154-182 BLISTER PACK (BLISTER PACK) in 1 CARTON
1NDC:52389-154-099 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:52389-154-363 BLISTER PACK (BLISTER PACK) in 1 CARTON
2NDC:52389-154-1212 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34004/08/1993
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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