Label: EXCEDRIN MIGRAINE GELTABS- acetaminophen, asprin, caffeine tablet, coated
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NDC Code(s):
0067-2035-16,
0067-2035-20,
0067-2035-24,
0067-2035-50, view more0067-2035-80, 0067-2035-91
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 28, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each GelTab)
- Purposes
- Use
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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 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
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
- Keep out of reach of children.
- Directions
- Other information
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Inactive ingredients
benzoic acid, D&C yellow #10 aluminum lake, disodium EDTA, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, ferric oxide, gelatin, glycerin, hydroxypropylcellulose, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
- Questions?
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Principal Display Panel
0067-2035-20
See new warnings information
Excedrin®
Migraine
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain reliever / Pain Reliever Aid
20GELTABS*
*GELATIN COATED TABLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer HealthcareWarren, NJ 07059
©2017 GSK or its licensor.
Visit us at www.excedrin.com
62000000012939
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INGREDIENTS AND APPEARANCE
EXCEDRIN MIGRAINE GELTABS
acetaminophen, asprin, caffeine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE RED (UNII: 1K09F3G675) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LIGHT MINERAL OIL (UNII: N6K5787QVP) MALTITOL (UNII: D65DG142WK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPSIN (UNII: GID333S43J) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green (dark green) , white Score no score Shape ROUND Size 18mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2035-20 1 in 1 CARTON 09/13/2011 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2035-24 1 in 1 CARTON 09/13/2011 12/31/2014 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0067-2035-50 1 in 1 CARTON 09/13/2011 12/31/2014 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0067-2035-80 1 in 1 CARTON 09/13/2011 4 80 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0067-2035-91 2 in 1 CARTON 09/13/2011 12/31/2014 5 100 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0067-2035-16 2 in 1 CARTON 09/13/2011 12/31/2014 6 160 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020802 09/13/2011 Labeler - Haleon US Holdings LLC (079944263)
