Excedrin Es Cvp 4 Count Carton

Excedrin Es Cvp 4 Count Carton
SPL v8
SPL
SPL Set ID 07c4cc3d-9a68-42a1-801d-5d4ec107ffad
Route
ORAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Indications and Usage

temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps

Dosage and Administration

do not use more than directed drink a full glass of water with each dose adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours under 12 years: 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition

Section 50568-5

a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition

Section 50569-3

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

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® EXTRA STRENGTH 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 at 20 weeks or later in 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)

temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps

Dosage and Administration (34068-7)

do not use more than directed drink a full glass of water with each dose adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours under 12 years: 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition

Section 50568-5 (50568-5)

a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition

Section 50569-3 (50569-3)

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

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® EXTRA STRENGTH 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 at 20 weeks or later in 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


Raw Label Data

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