SPL v1
SPL
SPL Set ID bade9e73-0f28-4914-ad25-fe11493d9c27
Route
ORAL
Published
Effective Date 2019-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (110 1) Aspirin (162 1) Salicylamide (152 1) Caffeine (32.4 1)
Inactive Ingredients
Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Starch, Corn Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-04-07

Description

ACTIVE INGREDIENT IN EACH TABLET - ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG


Medication Information

Warnings and Precautions

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 behaviour 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.

Alergy 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 8 tablets 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:

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take with 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:

• with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• with any other pain reliever/fever reducer

• if you are allergic to aspirin

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

Ask doctor before using if you have:

• stomach problems (such as heartburn, upset stomach or stomach pain)

• stomach bleeding warning applies to you

• gastric ulcers • bleeding problems

• you have asthma, high blood pressure, heart disease, liver disease, or kidney disease

• you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

•anticoagulation (thinning of blood) • diabetes • gout • arthritis

• und a doctor's care for any serious condition

• taking any other drug

When using this product do not exceed recommended dose.

Stop use and ask a doctor if:

• ringing in the ears or loss of hearing occurs

• pain or fever persists or gets worse

• new symptoms occur

• redness or swelling is present

• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.

• an allergic reaction occurs.

Seek medical help right away.

Indications and Usage

Uses:

temporarily relieves minor aches and pains associated with:

• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

Dosage and Administration

Adults and children 12 years of age and older:Take 2 tablets every 4 hours as

 needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

Children under 12 years: ask a doctor.

Description

ACTIVE INGREDIENT IN EACH TABLET - ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid

Section 51945-4

Section 53414-9

If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT

MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

Section 55105-1

PAIN RELIEVER/FEVER REDUCER 

Section 55106-9

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG


Structured Label Content

Indications and Usage (34067-9)

Uses:

temporarily relieves minor aches and pains associated with:

• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:Take 2 tablets every 4 hours as

 needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

Children under 12 years: ask a doctor.

Warnings and Precautions (34071-1)

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 behaviour 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.

Alergy 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 8 tablets 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:

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take with 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:

• with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• with any other pain reliever/fever reducer

• if you are allergic to aspirin

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

Ask doctor before using if you have:

• stomach problems (such as heartburn, upset stomach or stomach pain)

• stomach bleeding warning applies to you

• gastric ulcers • bleeding problems

• you have asthma, high blood pressure, heart disease, liver disease, or kidney disease

• you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

•anticoagulation (thinning of blood) • diabetes • gout • arthritis

• und a doctor's care for any serious condition

• taking any other drug

When using this product do not exceed recommended dose.

Stop use and ask a doctor if:

• ringing in the ears or loss of hearing occurs

• pain or fever persists or gets worse

• new symptoms occur

• redness or swelling is present

• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.

• an allergic reaction occurs.

Seek medical help right away.

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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)

PAIN RELIEVER/FEVER REDUCER 

Section 55106-9 (55106-9)

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG


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