Caffeine 200 mg tablet, multilayer
Otc - active ingredient section
Caffeine USP Anhydrous- 200 mg
Otc - purpose section
Purpose: Alertness Aid
Indications & usage section
Uses: 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 coffee. 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 heartbeat.
Otc - do not use section
Do Not Use: In children under 12 years old; as a substitute for sleep.
Drug interactions section
Drug Interaction Precaution: Do not take with other caffeine-containing medications
Otc - stop use section
Stop use and ask a doctor: If fatigue or drowsiness persists or continues to recur.
Otc - pregnancy or breast feeding section
If pregnant or breastfeeding, ask a health professional before using this product
Otc - keep out of reach of children section
Keep this and all medicines out of the reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & administration section
Directions: Adults and children 12 years of age or older: 1 tablet, not more often than every 3-4 hours.
Other safety information
Other Information: Keep this product protected from extremes of moisture, heat and light. Store in the temperature range of 15 to 30 Celsius (59 to 86 Fahrenheit).
Caution: For manufacturing, processing or repackaging [21CFR201.122]. This bulk shipment is not to be distributed for consumption in its present form and should be repackaged before the bulk container expiration date listed on this label and labeled in conformance with the Federal Food, Drug and Cosmetic Act and regulations thereunder.
Inactive ingredient section
Inactive ingredients: D&C red #27, dibasic calcium phosphate, FD&C blue #1, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid, sucrose
Ingredients and appearance - Product information
Caffeine 200 mg tablet, multilayer- M941l
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 62959-941|
|Route of Administration||Oral|
|Caffeine ( UNII: 3G6A5W338E)( Caffeine - UNII: 3G6A5W338E )||200 mgin 200 mg|
|D&c red no. 27||( UNII: 2LRS185U6K)|
|Dibasic calcium phosphate dihydrate||( UNII: O7TSZ97GEP)|
|Fd&c blue no. 1||( UNII: H3R47K3TBD)|
|Magnesium stearate||( UNII: 70097M6I30)|
|Cellulose, microcrystalline||( UNII: OP1R32D61U)|
|Povidone||( UNII: FZ989GH94E)|
|Silicon dioxide||( UNII: ETJ7Z6XBU4)|
|Stearic acid||( UNII: 4ELV7Z65AP)|
|Sucrose||( UNII: C151H8M554)|
|Color||white (with bluespecks;pink)||Shape||capsule|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC monograph final||part340||USA|
Labeler - ULTRAtab Laboratories, Inc.( 151051757)
|ULTRAtab Laboratories, Inc.||151051757||manufacture( 62959-941)|