Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Caffeine
FDA Label NDC 80136-855
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Caffeine (NDC 80136-855). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, use, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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 heartbeat.
Otc - Do Not Use
Do not use
■ in children under 12 years of age
■ as substitute for sleep
Otc - Stop Use
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 65 mg
■ Store in a dry place at 15° – 30°C (59° – 86°F)
Inactive Ingredient
corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica
Questions Or Comments?
1-800-231-4670
Other
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Distributed by:
NORTHEAST PHARMA
South Burlington, VT 05403
www.heartlandpharmaco.com
1-800-383-0648
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by LIL' DRUG STORE PRODUCTS, INC., owner of the registered trademark Maximum Strength NoDoz®.
Package Label.Principal Display Panel
NDC 80136-855-26
Compare to active ingredient in Maximum Strength NoDoz ®*
Heartland Pharma Co.
Maximum Strength
Caffeine Tablets
Caffeine, 200 mg
Alertness Aid
60 Tablets
* Please review the disclaimer below.
