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Drug Labeling and Warnings

Drug Details [pdf]

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

PEP-BACK  ULTRA
caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-154
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-154-18	2 in 1 CARTON	03/01/2011	08/31/2018
1	NDC: 52389-154-09	9 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-154-36	3 in 1 CARTON	09/15/2008	06/12/2012
2	NDC: 52389-154-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	04/08/1993	08/31/2018

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 4/2019

Document Id: 8736b9e9-86b8-3ea3-e053-2991aa0ab90b

34390-5

Set id: f9759c55-5d57-4fc4-9fa4-97fc117ab42e

Version: 5

Effective Time: 20190423