SOHMED ALERTNESS AID- caffeine tablet 
SOHM 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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SohMed™ Alertness Aid

Drug Facts

Active ingredients (in each caplet)

Caffeine 200 mg

Purpose

Alertness aid

Use

Warnings

For occasional use only

Caffeine warning

  • The recommended dose of this product contains about as much caffeine as a cup of cofffee.
  • Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

Do not use

  • in children under 12 years of age
  • as substitute for sleep

Stop use and ask a doctor if drowsiness persists or continues to recur fatigue or

If pregnant or breast-feeding, 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

Other information

Inactive ingredients

benzoic acid, corn starch, FD&C blue # 1, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, sucrose, titanium dioxide, carnauba wax.

Question or comments?

1(856) 2863646

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

SohMed

NDC XXXXXXXXXX

*Compare to the Active Ingredients in Vivarin®

ALERTNESS AID
Caffeine
Caffeine 200 mg

Restore mental alertness or wakefulness

24 Caplets

Principal Display Panel - 24 Caplet Bottle Carton
SOHMED ALERTNESS AID 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine200 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize11mm
FlavorImprint Code CRX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50405-005-241 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34008/25/2013
Labeler - SOHM Inc. (009303848)

Revised: 8/2013
Document Id: 80ebd529-8309-4e99-aad8-11ea709ca5f7
Set id: b7771094-0d9d-4811-8d60-1e550befef5c
Version: 1
Effective Time: 20130820
 
SOHM Inc.