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NDC 36800-0934-60 topcare migraine relief 250; 250; 65 mg/1; mg/1; mg/1 Details
topcare migraine relief 250; 250; 65 mg/1; mg/1; mg/1
topcare migraine relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
| NDC | 36800-0934 |
|---|---|
| Product ID | 36800-934_a7560b7b-c1dd-4cc0-a552-2b1b990f2544 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | topcare migraine 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 | Topco Associates LLC |
| 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 36800-0934-60 (36800093460)
| NDC Package Code | 36800-934-60 |
|---|---|
| Billing NDC | 36800093460 |
| Package | 1 BOTTLE in 1 CARTON (36800-934-60) / 20 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2022-06-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9163ecfe-6493-46eb-a08d-b4134d84b0ab Details
Active ingredients (in each geltab)
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
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- blisters
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- 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:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 2 geltabs 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
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- have had stomach ulcers or bleeding problems
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- 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)
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- 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
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- 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
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- you experienced your first headache after the age of 50
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- 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
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- 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:
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- diabetes
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- gout
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- arthritis
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- under a doctor’s care for any serious condition
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- 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.
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- 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
INGREDIENTS AND APPEARANCE
| TOPCARE MIGRAINE RELIEF
acetaminophen, aspirin, caffeine tablet, film coated |
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| Labeler - Topco Associates LLC (006935977) |
Revised: 6/2022
Document Id: a7560b7b-c1dd-4cc0-a552-2b1b990f2544
Set id: 9163ecfe-6493-46eb-a08d-b4134d84b0ab
Version: 2
Effective Time: 20220628