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Signature Care Migraine Relief
acetaminophen, aspirin, caffeine · Signature Care Migraine Relief is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin, caffeine, made by Safeway.
- Type
- Over the counter
- Drug class
- Central Nervous System Stimulant
- Route
- Oral
- Manufacturers
- 1
• treats migraine
Drug facts
- Generic name
- acetaminophen, aspirin, caffeine
- Active ingredients
- Acetaminophen, Aspirin, Caffeine
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- How it works
- Cyclooxygenase Inhibitors
- Dosage forms
- Tablet, film coated
- Label holder
- Safeway
- FDA application
- ANDA075794
- Label updated
- 03/27/2024
Active ingredients
(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever aid
Uses
- Treats migraine
Directions
- Do not use more than directed
- Adults: take 2 caplets with a glass of water
- If symptoms persist or worsen, ask your doctor
- Do not take more than 2 caplets in 24 hours, unless directed by a doctor
- Under 18 years of age: ask a doctor
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash If a skin reaction occurs, stop use and seek medical help right away. Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- Hives
- Facial swelling
- Asthma (wheezing)
- Shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- More than 2 caplets in 24 hours, which is the maximum daily amount
- With other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product 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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- Have 3 or more alcoholic drinks every day while using this product
- Take more or for a longer time than directed Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. 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 heart beat. Do not use
- If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if
- You have never had migraines diagnosed by a health professional
- You have a headache that is different from your usual migraines
- You have the worst headache of your life
- You have fever and stiff neck
- You have headaches beginning after or caused by head injury, exertion, coughing or bending
- You experienced your first headache after the age of 50
- You have daily headaches
- You have a migraine so severe as to require bed rest
- You have liver disease
- Stomach bleeding warning 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
- You have problems or serious side effects from taking pain relievers or fever reducers
- You have vomiting with your migraine headache Ask a doctor or pharmacist before use if you are
- Taking a prescription drug for:
- Diabetes
- Gout
- Arthritis
- Under a doctor’s care for any serious condition
- Taking any other drug
- Taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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
- Your migraine is not relieved or worsens after first dose
- New or unexpected symptoms occur
- Ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not use
- If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask a doctor before use
If
- You have never had migraines diagnosed by a health professional
- You have a headache that is different from your usual migraines
- You have the worst headache of your life
- You have fever and stiff neck
- You have headaches beginning after or caused by head injury, exertion, coughing or bending
- You experienced your first headache after the age of 50
- You have daily headaches
- You have a migraine so severe as to require bed rest
- You have liver disease
- Stomach bleeding warning 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
- You have problems or serious side effects from taking pain relievers or fever reducers
- You have vomiting with your migraine headache
Ask a doctor or pharmacist before use
- Taking a prescription drug for:
- Diabetes
- Gout
- Arthritis
- Under a doctor’s care for any serious condition
- Taking any other drug
- Taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
Stop use and ask a doctor
- 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
- Your migraine is not relieved or worsens after first dose
- New or unexpected symptoms occur
- Ringing in the ears or loss of hearing occurs
Pregnancy or breastfeeding
Ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information
- Store at 20 ° -25 ° C (68 ° -77 ° F)
- Close cap tightly after use
- Read all product information before using. Keep this box for important information.
Inactive ingredients
Carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide
Questions?
1-800-719-9260
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, film coated | 250 mg / 250 mg / 65 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- SafewayShown hereANDA075794 · Label 03/27/2024 · NDC 21130-569Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
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Signature Care Migraine Relief: common questions
- What is Signature Care Migraine Relief used for?
- • treats migraine
- Is Signature Care Migraine Relief a prescription drug?
- No. Signature Care Migraine Relief is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Signature Care Migraine Relief?
- Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength.
- Who makes Signature Care Migraine Relief?
- Safeway lists Signature Care Migraine Relief with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/27/2024 · Label text is shown as published by the manufacturer. Not medical advice