OTC Medication Information: Caffeine

CAFFEINE- caffeine tablet
CVS Pharmacy

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.

Active ingredient (in each tablet)

Caffeine 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
  • 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 and over: take 1 tablet not more often than every 3 to 4 hours

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dextrose, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS Health

Compare to the active
ingredient in Vivarin® *

NDC 59779-226-21

Caffeine Tablets
CAFFEINE, 200 mg

Alertness aid

• For mental alertness
• Safe & effective

16 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Meda Consumer Healthcare, owner of the registered trademark Vivarin®.
50844 ORG041222621

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112

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CVS Health 44-226
(click image for full-size original)

CVS Health 44-226

CAFFEINE
caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-226
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
DEXTROSE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;226
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-226-21 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (59779-226-21)
2 NDC:59779-226-10 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (59779-226-10)
3 NDC:59779-226-31 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 80 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-226-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 11/21/1996
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (59779-226)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (59779-226)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (59779-226)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (59779-226)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (59779-226)

Revised: 03/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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