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NDC 00067-2035-80 Excedrin 250; 250; 65 mg/1; mg/1; mg/1 Details
Excedrin 250; 250; 65 mg/1; mg/1; mg/1
Excedrin is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
| NDC | 00067-2035 |
|---|---|
| Product ID | 0067-2035_edbb64b9-f8ba-48db-8a36-d5837114f822 |
| Associated GPIs | 64990003200350 |
| 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 | Brand |
| Proprietary Name | Excedrin |
| Proprietary Name Suffix | Migraine Geltabs |
| Non-Proprietary Name | Acetaminophen, Asprin, Caffeine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, 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 | GlaxoSmithKline Consumer Healthcare Holdings (US) 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 | NDA |
| Application Number | NDA020802 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00067-2035-80 (00067203580)
| NDC Package Code | 0067-2035-80 |
|---|---|
| Billing NDC | 00067203580 |
| Package | 1 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE |
| Marketing Start Date | 2011-09-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8 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.
- •
- 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
Keep out of reach of children.
Directions
Other information
Inactive ingredients
benzoic acid, D&C yellow no. 10 aluminum lake, edetate disodium, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, ferrosoferric oxide, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
Additional Information
Principal Display Panel
INGREDIENTS AND APPEARANCE
| EXCEDRIN
MIGRAINE GELTABS
acetaminophen, asprin, caffeine tablet, coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |