caffeine 200 mg/1
caffeine · TABLET · Aurohealth LLC
caffeine is a tablet containing caffeine at 200 mg/1, taken oral. Manufactured by Aurohealth LLC.
Key Facts
- Brand Name
- caffeine
- Generic Name
- caffeine
- NDC Code (Product)
58602-747- Manufacturer
- Aurohealth LLC
- Strength
- 200 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M011
- Drug Class
- Central Nervous System Stimulant [EPC]; Methylxanthine [EPC]
- Marketing Start
- 07/04/2024
Recall History
Novartis Consumer Health
Defective container: products are packaged in pouches which may not have been fully sealed
ULTRAtab Laboratories, Inc.
CGMP Deviations
Ultra Seal Corporation
cGMP deviations
LNK International, Inc.
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Ultra Seal Corporation
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Ultra Seal Corporation
cGMP deviations
Ultra Seal Corporation
cGMP deviations
King Bio Inc.
Microbial contamination
Ultra Seal Corporation
cGMP deviations
Bayer Healthcare, LLC
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Dosage & Administration
DOSAGE AND ADMINISTRATION 1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Warnings
WARNINGS Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is high in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exa…
Contraindications
CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
Drug Interactions
Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Adverse Reactions
ADVERSE REACTIONS Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation. Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis. Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potent…
Frequently Asked Questions
What is caffeine used for?
caffeine contains caffeine. It is a tablet taken oral. Consult your doctor for specific uses.
Is caffeine a controlled substance?
caffeine is not classified as a controlled substance by the DEA.
What is the generic name for caffeine?
The generic name for caffeine is caffeine. There are 12 other brand versions of caffeine.
What is the NDC code for caffeine 200 mg/1?
The NDC (National Drug Code) for caffeine 200 mg/1 is 58602-747, listed by Aurohealth LLC.
Other Caffeine Brands
See all →- Uplift Chewable1 g/108.27g82876-831
- Uplift Chewable1 g/108.27g82876-833
- Stay Awake200 mg/183059-0097
- Stay Awake200 mg/183324-074
- caffeine citrate20 mg/mL25021-601
- Caffeine Citrate20 mg/mL47335-290
- TEXACLEAR PAIN RELIEVER65 mg/30mL58809-389
- Caffeine Citrate20 mg/mL63323-406
- Stay Awake200 mg/163868-114
- PAIN RELIEF CAFFEINE AND HEMP6 [hp_X]/mL73002-321
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)