Caffeine 200 mg

Drug Labeling and Warnings

Drug Details [pdf]

CAFFEINE 200 MG- m941l tablet, multilayer 
ULTRAtab Laboratories, 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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Caffeine 200 mg

Caffeine USP Anhydrous- 200 mg

Purpose: Alertness Aid

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.

Do Not Use: In children under 12 years old; as a substitute for sleep.

Drug Interaction Precaution: Do not take with other caffeine-containing medications

Stop use and ask a doctor: If fatigue or drowsiness persists or continues to recur.

If pregnant or breastfeeding, ask a health professional before using this product

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.

Directions: Adults and children 12 years of age or older: 1 tablet, not more often than every 3-4 hours.

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 [21CFR§201.122]. 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 ingredients: D&C red #27, dibasic calcium phosphate, FD&C blue #1, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid, sucrose

CAFFEINE 200 MG 
m941l tablet, multilayer

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg  in 200 mg

Inactive Ingredients
Ingredient Name	Strength
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)	Score	no score
Shape	capsule	Size	15mm
Flavor		Imprint Code	357HR;MAGNUM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62959-941-00	18000 mg in 1 PACKAGE; Type 0: Not a Combination Product	04/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	04/06/2016

Labeler - ULTRAtab Laboratories, Inc. (151051757)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

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

Revised: 11/2018

Document Id: f69baac5-a062-4f53-a367-25cba7eb0701

34390-5

Set id: 7baec4ed-7814-4fdc-9869-02215b507f13

Version: 7

Effective Time: 20181129