FDA Label for Cafiaspirina Rapid Headache Relief
View Indications, Usage & Precautions
Cafiaspirina Rapid Headache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Belmora Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredients (In Each Powder Stick Pack)
Aspirin 845 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever / fever reducer
Pain reliever aid
Uses:
temporarily relieves minor aches and pains associated with: headache, toothache, menstrual cramps, minor arthritis pain, muscular aches, colds, temporarily reduces fever.
Warnings:
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing). Stomach bleeding warning: this product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for longer time than directed. 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: if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if: • stomach bleeding warnings applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma.
Ask a doctor or pharmacist before use if: • you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
Stop use and ask a doctor if: • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over: take 1 powder stick pack every 6 hours while symptoms persist. Powder may be placed on tongue, then swallowed while drinking a full glass of water or may be stirred into a glass of water or other liquid before drinking. • do not take more than 4 powders in 24 hours unless directed by a doctor.
Children under 12 years of age:ask a doctor.
Other Information:
Each powder stick pack contains: potassium 55 mg • store below 25°C (77°F)
Inactive Ingredients:
docusate sodium, fumaric acid, lactose monohydrate, potassium chloride, sodium benzoate
Questions Or Comments?
1-888-779-2877 M-F 9AM-5PM EST
Belmora LLC, 3033 Wilson Blvd., Suite 700 Arlington, VA 22201
Packaging
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