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| Product NDC Code | 80136-855 | ||||
|---|---|---|---|---|---|
| Drug Name | Caffeine |
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| Type | Generic | ||||
| 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 | ||||
| RxCUI drug identifier | 198520 | ||||
| Application Number | part340 | ||||
| Labeler Name | Northeast Pharma | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Caffeine
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) Caffeine 200 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 ■ adults and children 12 years of age and over : take 1/2 to 1 tablet not more often than every 3 to 4 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica
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.Caffeine Caffeine DIBASIC CALCIUM PHOSPHATE DIHYDRATE CROSCARMELLOSE SODIUM MICROCRYSTALLINE CELLULOSE STARCH, CORN CAFFEINE CAFFEINE SILICON DIOXIDE MAGNESIUM STEARATE 212;212
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.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 Harland Pharma
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.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®.
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 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each tablet contains : calcium 65 mg ■ Store in a dry place at 15° – 30°C (59° – 86°F)
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? 1-800-231-4670
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 recur.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.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 of age ■ as 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.
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