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Jet alert regular strength - Medication Information

Product NDC Code 15579-201
Drug Name

Jet alert regular strength

Type Brand
Pharm Class Central Nervous System Stimulant [EPC],
Central Nervous System Stimulation [PE],
Methylxanthine [EPC],
Xanthines [CS]
Active Ingredients
Caffeine 100 mg/1
Route ORAL
Dosage Form TABLET, COATED
RxCUI drug identifier 308853,
1595393
Application Number M011
Labeler Name Bell Pharmaceuticals, Inc
Packages
Package NDC Code Description
15579-201-09 1 bottle in 1 carton (15579-201-09) / 30 tablet, coated in 1 bottle
15579-201-20 1 bottle in 1 carton (15579-201-20) / 120 tablet, coated in 1 bottle
15579-201-35 3 blister pack in 1 box (15579-201-35) / 10 tablet, coated in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Caffeine 100 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions take 1 tablet not more often than every 3 to 4 hours. • adults and children 12 years of age and over:

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients calcium stearate, lactose, microcrystalline cellulose, silicon dioxide.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps to restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Purpose

Information about the drug product’s indications for use.
Purpose Alertness Aid

Spl product data elements

Usually a list of ingredients in a drug product.
JET ALERT Regular Strength CAFFEINE CALCIUM STEARATE LACTOSE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE CAFFEINE CAFFEINE 100

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: label tablet Package Labeling: Label01

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information • store at room temperature between 59°-86°F (15°-30°C) • protect from excessive moisture • do not use if tamper-evident seal is broken or missing Questions? 1-800-328-5890 Weekdays 8:30-5:00 CST

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use • in children under 12 years of age • as a substitute for sleep

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if fatigue or drowsiness • persists • continues to recur

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product 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. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 while taking this product 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 • 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API