Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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.

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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

• in children under 12 years of age
• as a substitute for sleep

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

• adults and children 12 years of age and over: take ½ to 1 caplet not more often than every 3 to 4 hours

Other information

• store at controlled room temperature of 20-25°C (68-77°F)

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.

12762

NODOZ  MAXIMUM STRENGTH ALERTNESS AID
caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-2070
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (Off-White)	Score	2 pieces
Shape	OVAL (Caplet)	Size	15mm
Flavor		Imprint Code	NoDoz
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-2070-60	1 in 1 CARTON	12/31/2009	07/11/2019
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	12/31/2009	07/11/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2018

Document Id: 89a9d8ce-facb-4476-b2df-3717973a1b10

34390-5

Set id: 7ef8b03c-245a-424f-bf75-438559c4418b

Version: 4

Effective Time: 20180810

 

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC