EXCEDRIN MIGRAINE acetaminophen aspirin (nsaid) and caffeine tablet film coated

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

इसे खरीदें

सक्रिय संघटक:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
थमां उपलब्ध:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
INN (इंटरनेशनल नाम):
ACETAMINOPHEN
रचना:
ACETAMINOPHEN 250 mg
प्रिस्क्रिप्शन प्रकार:
OTC DRUG
प्राधिकरण का दर्जा:
Abbreviated New Drug Application

EXCEDRIN MIGRAINE- acetaminophen, aspirin (nsaid) and caffeine tablet, film coated

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

----------

Drug Facts

Active ingredient

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

treats migraines

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 caplets 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

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 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:

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:

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.

Directions

do not use more than directed

adults: take 2 caplets with a glass of water

if symptoms persist or worsen, ask your doctor

do not take more than 2 caplets in 24 hours, unless directed by a doctor

under 18 years of age: ask a doctor

diabetes

gout

arthritis

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

Other information

store at 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

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose,

povidone, pregeletanized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Principal Display Panel

NDC 0067-8103-50

EXCEDRIN

MIGRAINE

Acetaminophen, Aspirin (NSAID) and Caffeine Tablets

Pain Reliever / Pain Reliever Aid

50 COATED CAPLETS**

**CAPSULE-SHAPED TABLETS

DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS BROKEN OR MISSING

KEEP BOX FOR REFERENCE

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2014

Visit us at www.excedrin.com

12041

®

EXCEDRIN MIGRAINE

acetaminophen, aspirin (nsaid) and caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 0 6 7-8 10 3

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

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

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

CAPSULE ((capsule shaped tablet))

S iz e

17mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 6 7-8 10 3-24

1 in 1 CARTON

10 /22/20 12

0 2/10 /20 16

1

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

2

NDC:0 0 6 7-8 10 3-30

1 in 1 CARTON

10 /14/20 14

0 6 /0 7/20 16

2

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

3

NDC:0 0 6 7-8 10 3-9 1

1 in 1 CARTON

10 /22/20 12

12/30 /20 15

3

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

4

NDC:0 0 6 7-8 10 3-8 3

1 in 1 CARTON

10 /14/20 14

0 3/29 /20 16

4

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

5

NDC:0 0 6 7-8 10 3-9 2

1 in 1 CARTON

10 /22/20 12

12/21/20 15

5

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

6

NDC:0 0 6 7-8 10 3-33

1 in 1 CARTON

10 /22/20 12

0 2/0 8 /20 16

6

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:0 0 6 7-8 10 3-50

1 in 1 CARTON

11/13/20 14

0 3/0 7/20 18

7

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

8

NDC:0 0 6 7-8 10 3-77

1 in 1 CARTON

10 /19 /20 15

0 4/0 1/20 16

8

250 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

ANDA

ANDA0 7579 4

10 /22/20 12

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 4/2017

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