Cafiaspirina Rapid Headache Relief

Cafiaspirina Rapid Headache Relief
SPL v1
SPL
SPL Set ID d890acec-6528-4fb7-8d59-6c572a3f0786
Route
ORAL
Published
Effective Date 2024-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (845 mg) Caffeine (65 mg)
Inactive Ingredients
Docusate Sodium Fumaric Acid Lactose Monohydrate Potassium Chloride Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

Aspirin 845 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer Pain reliever aid


Medication Information

Purpose

Pain reliever / fever reducer

Pain reliever aid

Description

Aspirin 845 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Uses:

temporarily relieves minor aches and pains associated with: headache, toothache, menstrual cramps, minor arthritis pain, muscular aches, colds, temporarily reduces fever.

Section 42229-5

Minor Body Aches

TAMPER EVIDENT FEATURE: DO NOT USE IF STICK PACK IS DAMAGED OR TORN.

REV. 9/23 HPDRR

Distributed By: Belmora, LLC | 1-888-779-2877

3033 Wilson Blvd., Suite 700 Arlington, VA 22201

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging

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.

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.

Drug Facts

Active Ingredients

Aspirin 845 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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


Structured Label Content

Uses:

temporarily relieves minor aches and pains associated with: headache, toothache, menstrual cramps, minor arthritis pain, muscular aches, colds, temporarily reduces fever.

Section 42229-5 (42229-5)

Minor Body Aches

TAMPER EVIDENT FEATURE: DO NOT USE IF STICK PACK IS DAMAGED OR TORN.

REV. 9/23 HPDRR

Distributed By: Belmora, LLC | 1-888-779-2877

3033 Wilson Blvd., Suite 700 Arlington, VA 22201

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Pain reliever / fever reducer

Pain reliever aid

Packaging

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.

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.

Drug Facts

Active Ingredients

Aspirin 845 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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? (Questions or Comments?)

1-888-779-2877 M-F 9AM-5PM EST

Belmora LLC, 3033 Wilson Blvd., Suite 700 Arlington, VA 22201


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