Caffeine 200 Mg: Package Insert and Label Information

CAFFEINE 200 MG- caffeine 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.

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

M641L
(click image for full-size original)

CAFFEINE 200 MG
m941l tablet, multilayer
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62959-941
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 200 mg in 200 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SILICON DIOXIDE
STEARIC ACID
SUCROSE
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 Multilevel Packaging
1 NDC:62959-941-00 18000 mg in 1 PACKAGE None
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 Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture (62959-941)

Revised: 11/2018 ULTRAtab Laboratories, Inc.

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