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 section

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.

Overdosage section

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 information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 62959-941
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Caffeine ( UNII: 3G6A5W338E)( Caffeine - UNII: 3G6A5W338E ) 200 mgin 200 mg

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Color white (with bluespecks;pink) Shape capsule
Size 15 mm Score 1
Imprint Code 357HR;MAGNUM

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part340 USA

Labeler - ULTRAtab Laboratories, Inc.( 151051757)

Establishment

Name ID/FEI Business Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture( 62959-941)

Package label.principal display panel