EXCEDRIN MIGRAINE GELTABS- acetaminophen, asprin, caffeine tablet, coated

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever Pain reliever aid
Authorization status:
New Drug Application
Authorization number:
0067-2035-16, 0067-2035-20, 0067-2035-24, 0067-2035-50, 0067-2035-80, 0067-2035-91

EXCEDRIN MIGRAINE GELTABS- acetaminophen, asprin, caffeine tablet, coated

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

----------

Drug Facts

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

Use

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:

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:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

treats migraine

skin reddening

blisters

rash

hives

facial swelling

asthma (wheezing)

shock

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

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

3 or more alcoholic drinks every day while using this product

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

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

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

taking a prescription drug for:

Stop use and ask a doctor if

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.

Directions

Other information

Inactive ingredients

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

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

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

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.

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

Ques tions ?

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

20 GELTABS*

*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 Healthcare Warren, NJ 07059

©2017 GSK or its licensor.

Visit us at www.excedrin.com

62000000012939

EXCEDRIN MIGRAINE GELTABS

acetaminophen, asprin, caffeine tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 0 6 7-20 35

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

250 mg

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

250 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

MALTITO L (UNII: D6 5DG142WK)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PEPSIN (UNII: GID333S43J)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYL GALLATE (UNII: 8 D4SNN7V9 2)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO RBITAN MO NO LAURATE (UNII: 6 W9 PS8 B71J)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

GREEN (dark green) , WHITE

S core

no sco re

S hap e

ROUND

S iz e

18 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 6 7-20 35-20

1 in 1 CARTON

0 9 /13/20 11

1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 0 6 7-20 35-24

1 in 1 CARTON

0 9 /13/20 11

12/31/20 14

2

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 0 6 7-20 35-50

1 in 1 CARTON

0 9 /13/20 11

12/31/20 14

3

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 0 6 7-20 35-8 0

1 in 1 CARTON

0 9 /13/20 11

4

8 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:0 0 6 7-20 35-9 1

2 in 1 CARTON

0 9 /13/20 11

12/31/20 14

5

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:0 0 6 7-20 35-16

2 in 1 CARTON

0 9 /13/20 11

12/31/20 14

6

16 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 8 0 2

0 9 /13/20 11

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Revised: 2/2018

Similar products

Search alerts related to this product

Share this information