Label: SOHMED ALERTNESS AID- caffeine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50405-005-24 - Packager: SOHM Inc.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated August 20, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each caplet)
- Purpose
- Use
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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.
- Directions
- Other information
- Inactive ingredients
- Question or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton
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INGREDIENTS AND APPEARANCE
SOHMED ALERTNESS AID
caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50405-005 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 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 Color BLUE Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code CRX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50405-005-24 1 in 1 CARTON 1 24 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part340 08/25/2013 Labeler - SOHM Inc. (009303848)