ALLERTNESS AID caffeine tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Chain Drug Consortium
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 200 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

ALLERTNESS AID- caffeine tablet

Chain Drug Consortium

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

Caffeine 200 mg

Purpos e

Alertness aid

Us es

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do Not Use

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

When Using this product

limit the use of caffeine containing medications, foods, or beverages because too much caffeine may

cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop Use and ask a doctor if

fatigue or drowsiness persists or continues to occur . For occasional use only.

If pregnancy or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center right away.

Directions

Adults and children 12 years of age and older: take 1 tablet not more often than every 3 to 4 hours

Children under 12 years of age: Do not use

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dicalcium phosphate dihydrate,

FD&C yellow #6, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose,

propylene glycol, titanium dioxide, triacetin

Package/Label Principal Display Panel

ALLERTNESS AID

caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 16 -19 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Chain Drug Consortium

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 16 -19 5-0 3

16 in 1 BOX

2

NDC:6 8 0 16 -19 5-11

40 in 1 BOX

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

11/0 3/20 14

Labeler -

Chain Drug Consortium (101668460)

Registrant -

Chain Drug Consortium (101668460)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A&Z

Pharmaceutical, Inc.

9 26 8 20 70 5

LABEL(6 8 0 16 -19 5) , MANUFACTURE(6 8 0 16 -19 5) , PACK(6 8 0 16 -19 5) ,

RELABEL(6 8 0 16 -19 5) , REPACK(6 8 0 16 -19 5)

Revised: 11/2014

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