NODOZ MAXIMUM STRENGTH ALERTNESS AID- caffeine tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 200 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

NODOZ MAXIMUM STRENGTH ALERTNESS AID- CAFFEINE TABLET, COATED
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
_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._
----------
_DRUG FACTS_
_ACTIVE INGREDIENT (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
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
heart beat.
DO NOT USE
•
•
STOP USE AND ASK A DOCTOR IF
fatigue or drowsiness persists or continues to recur
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS_
•
_OTHER INFORMATION_
in children under 12 years of age
as a substitute for sleep
adults and children 12 years of age and over: take ½ to 1 caplet not
more often than every 3 to 4
hours
•
_INACTIVE INGREDIENTS_
benzoic acid, carnauba wax, 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
_QUESTIONS OR COMMENTS?_
1-800-468-7746
WWW.NODOZ.COM
PRINCIPAL DISPLAY PANEL
NDC 0067-2070-60
_NODOZ®_
_MAX STRENGTH ● FAST ACTING_
_ALERTNESS AID_
60 CAPLETS
200 mg CAFFEINE EACH
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL PIRNTED WITH “SEALED FOR YOUR
PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK CONSUMER HEALTHCARE
WARREN, NJ 07059
©2016 GSK or its licensor. All rights reserved.
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