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Excedrin Migraine Geltabs: Package Insert / Prescribing Info

Package insert / product label
Generic name: acetaminophen, asprin, caffeine
Dosage form: tablet, coated
Drug class: Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

Active ingredients (in each GelTab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Indications and Usage for Excedrin Migraine Geltabs

  • treats migraine

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

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Related/similar drugs

Excedrin Migraine Geltabs Dosage and Administration

  • do not use more than directed
  • adults: take 2 geltabs with a glass of water
  • if symptoms persist or worsen, ask your doctor
  • do not take more than 2 geltabs in 24 hours, unless directed by a doctor
  • under 18 years of age: ask a doctor

Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.

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?

1-800-452-0051

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

62000000012939_Excedrin Geltabs_20 ct.JPG
EXCEDRIN MIGRAINE GELTABS
acetaminophen, asprin, caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (dark green) , whiteScoreno score
ShapeROUNDSize18mm
FlavorImprint CodeE
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2035-201 in 1 CARTON09/13/2011
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-2035-241 in 1 CARTON09/13/201112/31/2014
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-2035-501 in 1 CARTON09/13/201112/31/2014
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-2035-801 in 1 CARTON09/13/2011
480 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-2035-912 in 1 CARTON09/13/201112/31/2014
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-2035-162 in 1 CARTON09/13/201112/31/2014
6160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080209/13/2011
Labeler - Haleon US Holdings LLC (079944263)