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NDC 00067-2021-24 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 | 00067-2021 |
|---|---|
| Product ID | 0067-2021_7cb14fb8-1195-4da3-b9d7-7375d26fa029 |
| Associated GPIs | 64990003200350 |
| 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 | Excedrin |
| Proprietary Name Suffix | Extra Strength 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 | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00067-2021-24 (00067202124)
| NDC Package Code | 0067-2021-24 |
|---|---|
| Billing NDC | 00067202124 |
| Package | 1 BOTTLE in 1 CARTON (0067-2021-24) / 24 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 11a8439b-0159-4351-b0f5-fe7fad6a33c0 Details
Active ingredients (in each GelTab)
Uses
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 8 geltabs 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
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 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
Ask a doctor or pharmacist before use if you are
taking
- •
- a prescription drug for diabetes, gout, or arthritis
- •
- any other drug, or are under a doctor’s care for any serious condition
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
- •
- ringing in the ears or loss of hearing occurs
- •
- painful area is red or swollen
- •
- pain gets worse or lasts for more than 10 days
- •
- fever gets worse or lasts for more than 3 days
- •
- any new symptoms appear
- These could be signs of a serious condition.
Directions
Other information
Inactive ingredients
benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
Principal Display Panel
NDC 0067-2021-20
EXCEDRIN
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
20 GELTABS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SELA IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor.
Visit us at www.excedrin.com
46172149
INGREDIENTS AND APPEARANCE
| EXCEDRIN
EXTRA STRENGTH GELTABS
acetaminophen, asprin, caffeine tablet, coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |