MIGRAINE RELIEF acetaminophen aspirin caffeine tablet film coated

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Safeway
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Prescription type:
OTC DRUG
Authorization status:
Abbreviated New Drug Application

MIGRAINE RELIEF- acetaminophen, aspirin, caffeine tablet, film coated

Safeway

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Safeway Inc. Migraine Relief Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever

Pain reliever aid

Us e

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 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

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

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:

diabetes

gout

arthritis

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. (1-800-222-1222)

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

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

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

Questions or comments?

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 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

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.

1-888-723-3929

Principal Display Panel

Migraine Relief

Acetaminophen, Aspirin (NSAID) and Caffeine Tablets

Pain Reliever/Pain Reliever Aid

Compare to Excedrin® Migraine active ingredients

24 COATED CAPLETS**

**Capsule-shaped tablets

MIGRAINE RELIEF

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -550

Safe way

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 (UNII: 6 8 40 19 6 0 MK)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

CAPSULE

S iz e

17mm

Flavor

Imprint Code

L374

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:21130 -550 -6 2

1 in 1 CARTON

1

24 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7579 4

0 7/28 /20 14

Labeler -

Safeway (009137209)

Revised: 7/2014

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