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Product NDC Code | 69168-076 | ||||||
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Drug Name | Stay awake |
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Type | Brand | ||||||
Pharm Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, COATED | ||||||
RxCUI drug identifier | 198520 | ||||||
Application Number | M011 | ||||||
Labeler Name | Allegiant Health | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient(s) Caffeine 200mg
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 Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours Children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium 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.Use helps 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.Stay Awake Caffeine CAFFEINE CAFFEINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE AZ;076
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.Principal Display Panel Stay Awake Stay Awake
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 20º-25ºC (68º-77º F). ■ avoid excessive heat (greater than 100°F) and humidity ■ do not use if blister package is torn or open or if imprinted seal under safety cap is broken or missing.
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, contact a doctor or Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-888-852-0050 Monday thru Friday 9am - 5pm EST
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 or continues to occur.
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 because too much caffeine may cause nervousness, irritability, sleep- lessness, and ocassionally 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 feedingPregnancy/Breastfeeding 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 because too much caffeine may cause nervousness, irritability, sleep- lessness, and ocassionally 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. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, contact a doctor or Poison Control Center right away (1-800-222-1222).
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