principal display panel - 2 caplet packet carton

principal display panel - 2 caplet packet carton
SPL v5
SPL
SPL Set ID 20406b7d-c989-40a5-b066-f3336c27a5fa
Route
oral
Published
Effective Date 2019-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Indications and Usage

treats migraine

Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

store at 20°-25°C (68°-77°F) read all product information before using. keep this box for important information

Section 50565-1

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.

Section 50566-9

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

benzoic acid, carnauba wax, FD & C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Section 51945-4

EXCEDRIN® MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 3 Packets of 2 Caplets

Section 53413-1

1-800-452-0051

Section 53414-9

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.

Section 55105-1

Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid


Structured Label Content

Indications and Usage (34067-9)

treats migraine

Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

store at 20°-25°C (68°-77°F) read all product information before using. keep this box for important information

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

benzoic acid, carnauba wax, FD & C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

EXCEDRIN® MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 3 Packets of 2 Caplets

Section 53413-1 (53413-1)

1-800-452-0051

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid


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