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NDC 63981-0699-01 kirkland signature migraine headache relief 250; 250; 65 mg/1; mg/1; mg/1 Details
kirkland signature migraine headache relief 250; 250; 65 mg/1; mg/1; mg/1
kirkland signature migraine headache relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Costco Wholesale Company. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
| NDC | 63981-0699 |
|---|---|
| Product ID | 63981-699_55fa8174-61c9-43ec-bc65-b39a687974c4 |
| Associated GPIs | 41550020100320 |
| GCN Sequence Number | 040186 |
| GCN Sequence Number Description | aspirin/acetaminophen/caffeine TABLET 250-250-65 ORAL |
| HIC3 | H3D |
| HIC3 Description | ANALGESIC/ANTIPYRETICS, SALICYLATES |
| GCN | 10414 |
| HICL Sequence Number | 001807 |
| HICL Sequence Number Description | ASPIRIN/ACETAMINOPHEN/CAFFEINE |
| Brand/Generic | Generic |
| Proprietary Name | kirkland signature migraine headache relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Aspirin, Caffeine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 250; 250; 65 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; ASPIRIN; CAFFEINE |
| Labeler Name | Costco Wholesale Company |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075794 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63981-0699-01 (63981069901)
| NDC Package Code | 63981-699-01 |
|---|---|
| Billing NDC | 63981069901 |
| Package | 400 TABLET, FILM COATED in 1 BOTTLE (63981-699-01) |
| Marketing Start Date | 2022-06-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 02e0b16b-7244-4819-8f0a-76dfad3e4d2b Details
Active ingredients (in each caplet)
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:
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- 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
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- more than 2 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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
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- are age 60 or older
- •
- have had stomach ulcers or bleeding problems
- •
- take a blood thinning (anticoagulant) or steroid drug
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- 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
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- 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
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- you have never had migraines diagnosed by a health professional
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- you have a headache that is different from your usual migraines
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- you have the worst headache of your life
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- you have fever and stiff neck
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- 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
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- you have a migraine so severe as to require bed rest
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- you have liver disease
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- stomach bleeding warning applies to you
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- 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
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- you have asthma
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have vomiting with your migraine headache
Ask a doctor or pharmacist before use if you are
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- taking a prescription drug for:
- •
- diabetes
- •
- gout
- •
- arthritis
- •
- under a doctor’s care for any serious condition
- •
- taking any other drug
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- taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
- •
- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- your migraine is not relieved or worsens after first dose
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- new or unexpected symptoms occur
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- ringing in the ears or loss of hearing occurs
Directions
Other information
Inactive ingredients
Principal Display Panel
KIRKLAND Signature
COMPARE TO EXCEDRIN® MIGRAINE active ingredients†
DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING
MIGRAINE HEADACHE RELIEF
Acetaminophen /Aspirin (NSAID)/Caffeine Tablets
Pain Reliever/Pain Reliever Aid
• Treats Migraine
Actual Size
400 COATED CAPLETS
Capsule-Shaped Tablets
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Migraine.
INGREDIENTS AND APPEARANCE
| KIRKLAND SIGNATURE MIGRAINE HEADACHE RELIEF
acetaminophen, aspirin, caffeine tablet, film coated |
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| Labeler - Costco Wholesale Company (103391843) |