SPL v1
SPL
SPL Set ID d49b5b7f-59af-40c5-a0ec-79f5bf8aa56c
Route
ORAL
Published
Effective Date 2015-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg) Acetaminophen
Inactive Ingredients
Caffeine Stearic Acid Cellulose, Microcrystalline Povidone K30 Starch, Pregelatinized Corn Titanium Dioxide Hypromelloses Maltodextrin Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-04-03

Description

Uses: for temporary relief of mild to moderate pain associated with BACKACHE, headache, colds. toothache, minor arthritis pain, muscular aches, menstrual cramps


Medication Information

Warnings and Precautions

Warnings:

Reye's syndrome: Children and teenagers should not

use this medicine for chicken pox or  u symptoms

before a doctor is consulted about Reye's syndrome, a

rare but serious illness reported to be associated with

aspirin.

Allergy Alert: Do not take this product if after

taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock

Alcohol Warning: If you consume 3 or more

alcoholic drinks every day, ask your doctor whether you

should take acetaminophen and aspirin or other pain

relievers/fever reducers. Acetaminophen and aspirin may

cause liver damage and stomach bleeding.

Ask a doctor before use if you have: • the worst headache of your life • ulcers

• fever and sti neck • asthma

• bleeding problems • liver disease

• renal disease

When using this product:

• limit the use of caffeine containing medications,

foods, or beverages while taking this product

because too much caFFeine may cause

nervousness, sleeplessness, irritability and,

occasionally, rapid heart beat.

Stop use and ask a doctor if:

• headache pain worsens or continues for more than 48 hours

• new or unexpected symptoms occur

• ringing in the ears or loss of hearing occur

Indications and Usage

Uses:

for temporary relief of mild to moderate pain

associated with BACKACHE, headache, colds. toothache, minor arthritis pain, muscular aches, menstrual cramps

Dosage and Administration

Directions:

Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 unless directed by a doctor.

Description

Uses: for temporary relief of mild to moderate pain associated with BACKACHE, headache, colds. toothache, minor arthritis pain, muscular aches, menstrual cramps

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. 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

Inactive Ingredients:

hydroxypropyl methylcellulose, maltodextrin,microcrystalline cellulose,polyethylene glycol

povidone, sodium starch glycolate, starch, and stearic acid

USP.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a

health professional before use. IT IS

ESPECIALLY IMPORTANT NOT TO USE

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 WITH ADJUVANT

Section 55106-9

ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, MAGNESIUM SALICYLAYE 250 MG,CAFFEINE 50 mg


Structured Label Content

Indications and Usage (34067-9)

Uses:

for temporary relief of mild to moderate pain

associated with BACKACHE, headache, colds. toothache, minor arthritis pain, muscular aches, menstrual cramps

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 unless directed by a doctor.

Warnings and Precautions (34071-1)

Warnings:

Reye's syndrome: Children and teenagers should not

use this medicine for chicken pox or  u symptoms

before a doctor is consulted about Reye's syndrome, a

rare but serious illness reported to be associated with

aspirin.

Allergy Alert: Do not take this product if after

taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock

Alcohol Warning: If you consume 3 or more

alcoholic drinks every day, ask your doctor whether you

should take acetaminophen and aspirin or other pain

relievers/fever reducers. Acetaminophen and aspirin may

cause liver damage and stomach bleeding.

Ask a doctor before use if you have: • the worst headache of your life • ulcers

• fever and sti neck • asthma

• bleeding problems • liver disease

• renal disease

When using this product:

• limit the use of caffeine containing medications,

foods, or beverages while taking this product

because too much caFFeine may cause

nervousness, sleeplessness, irritability and,

occasionally, rapid heart beat.

Stop use and ask a doctor if:

• headache pain worsens or continues for more than 48 hours

• new or unexpected symptoms occur

• ringing in the ears or loss of hearing occur

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. 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)

Inactive Ingredients:

hydroxypropyl methylcellulose, maltodextrin,microcrystalline cellulose,polyethylene glycol

povidone, sodium starch glycolate, starch, and stearic acid

USP.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a

health professional before use. IT IS

ESPECIALLY IMPORTANT NOT TO USE

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 WITH ADJUVANT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, MAGNESIUM SALICYLAYE 250 MG,CAFFEINE 50 mg


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