Otc - Active Ingredient
Active ingredient (in each tablet)
Caffeine 200mg
357 Super Magnum
FDA Label NDC 70682-941
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by King Richard Promotions Dba Dbi for the product 357 Super Magnum (NDC 70682-941). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, 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
Indications & Usage
Use: Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.
Warnings
Warnings: 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.
For occasional use only.Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.
Do not give to children under 12 years of age.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions: Adults and children 12 years of age or older: 1/2 to 1 tablet, not more often than every 3-4 hours.
Children under 12 years: do not use.
Other Safety Information
Other Information:
Each tablet contains: Calcium 48mg
Store at room temperature.
Avoid excess heat (greater than 100°F) or humidity.
Inactive Ingredient
Inactive ingredients: blue #1 lake, croscarmellose sodium*, dicalcium phosphate , magnesium silicate*, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, red #27 lake, silicon dioxide, stearic acid, sugar, and titanium dioxide*
*Contains one or more of these ingredients
Otc - Questions
Questions?
Call toll-free 1-800-428-2352 Monday through Friday, 8a.m. to 5p.m. EST.
Package Label.Principal Display Panel
357magnum36 (357 Magnum 36ctlabel R26131 0001)
* Please review the disclaimer below.
