PEP-BACK ULTRA- 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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Pep-Back

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) every 3 to 4 hours while symptoms persist, not to exceed 4 caplets in a 24 hour period.
  • 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, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, magnesium silicate, magnesium stearate, mineral oil, polyethylene glycol, sodium lauryl sulfate, stearic acid, and titanium dioxide.

Questions?  1-800-792-2582

ReCharge PDP

PEP-BACK  ULTRA
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-154-182 in 1 CARTON03/01/201108/31/2018
1NDC:52389-154-099 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:52389-154-363 in 1 CARTON09/15/200806/12/2012
2NDC:52389-154-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34004/08/199308/31/2018
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 4/2019
 
Alva-Amco Pharmacal Companies, Inc.