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Pep-Back Ultra

Medically reviewed on December 15, 2017

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) 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

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 
HYPROMELLOSES 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
MINERAL OIL 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
ETHYL VANILLIN 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint CodeALVA
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-154-182 BLISTER PACK in 1 CARTON
1NDC:52389-154-099 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:52389-154-363 BLISTER PACK in 1 CARTON
2NDC:52389-154-1212 TABLET, FILM COATED 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)

 
Alva-Amco Pharmacal Companies, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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