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NDC 69842-0500-11 Caffeine 200 mg/1 Details

Caffeine 200 mg/1

Caffeine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc.. The primary component is CAFFEINE.

Product Information

NDC	69842-0500
Product ID	69842-500_a8236c97-2060-6634-e053-2995a90a6a51
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Caffeine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Caffeine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CAFFEINE
Labeler Name	CVS Pharmacy, Inc.
Pharmaceutical Class	Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part340
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0500-11 (69842050011)

Pricing Information	N/A
NDC Package Code	69842-500-11
Billing NDC	69842050011
Package	1 BOTTLE in 1 CARTON (69842-500-11) / 60 TABLET in 1 BOTTLE
Marketing Start Date	2018-06-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6de63f21-c3b4-0c2f-e053-2991aa0a7886 Details

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

SPL UNCLASSIFIED SECTION

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

SPL UNCLASSIFIED SECTION

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 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 (1-800-222-1222) right away.

Directions

■ adults and children 12 years of age and over: take 1/2 to 1 tablet not more often than every 3 to 4 hours

Other Information

■ each tablet contains: calcium 63 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

SPL UNCLASSIFIED SECTION

corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Maximum Strength NoDoz®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS V-34571

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Maximum Strength NoDoz®*

MAXIMUM STRENGTH

Caffeine Tablets

CAFFEINE, 200 mg

Alertness aid

• Easy to swallow

• Fast acting

• Safe & ef fective

60 TABLETS

INGREDIENTS AND APPEARANCE

CAFFEINE

caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-500
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	212;212
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-500-11	1 in 1 CARTON	06/28/2018
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part340	06/28/2018

Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 9/2020

Document Id: a8236c97-2060-6634-e053-2995a90a6a51

Set id: 6de63f21-c3b4-0c2f-e053-2991aa0a7886

Version: 2

Effective Time: 20200923

Search by Drug Name or NDC

NDC 69842-0500-11 Caffeine 200 mg/1 Details

Caffeine 200 mg/1

Product Information

Package

Package Images

NDC 69842-0500-11 (69842050011)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6de63f21-c3b4-0c2f-e053-2991aa0a7886 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Directions

Other Information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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