Sohmed Alertness Aid
FDA Label NDC 50405-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sohm Inc. for the product Sohmed Alertness Aid (NDC 50405-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each caplet), purpose, use, warnings, caffeine warning, do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredients (In Each Caplet)

Caffeine 200 mg

Purpose

Alertness aid

Use

  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and over: take ½ to 1 caplet not more often than every 3 to 4 hours.

Other Information

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • See end flap for expiration date and lot number

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

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)

Principal Display Panel (24 Caplet Bottle Carton)

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