Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1b22a74e-8055-4388-ad74-d9b82213c9d6
Route
ORAL
Published
Effective Date 2010-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Starch, Pregelatinized Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 78 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1990-06-30

Description

Acetaminophen;     650 mg


Medication Information

Warnings and Precautions
LIVER  WARNING This product contains  acetaminophen.



severe liver damage may occur if adult takes more than 6 doses in 24 hours



which is the maximum daily amount.



child takes more than 5 doses in 24 hours



which is the maximum daily amount.



taken with other drugs containing acetaminophen.



adult has 3 or more alcoholic drinks everyday while using this product.
Indications and Usage

temporarily relieves minor aches and pains due to

common cold ; headaches ; toothaches ; muscular aches ;

backache ; minor arthritis pain ; menstrual cramps ; temporarily reduces fevers
Dosage and Administration

Directions

do not use more than directed

adults and children 12 years of age and older take 1 caplet

every 4 hours as needed.

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

children under 12 years of age;

do not use this adult product in children under 12 years of age

this will provide more than the recommended dose ( overdose ) of

non aspirin and could cause health problems.
Description

Acetaminophen;     650 mg

Section 50565-1

keep out of reach of children.

Section 51727-6

polyvinylpyrrolidone ; pregelaatinized starch ; sodium starch glycolate ;

stearic acid.

Section 51945-4

Section 55105-1
Acetaminophen 650 mg ;  pain reliever ; fever reducer
Section 55106-9

Acetaminophen;     650 mg


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor aches and pains due to

common cold ; headaches ; toothaches ; muscular aches ;

backache ; minor arthritis pain ; menstrual cramps ; temporarily reduces fevers
Dosage and Administration (34068-7)

Directions

do not use more than directed

adults and children 12 years of age and older take 1 caplet

every 4 hours as needed.

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

children under 12 years of age;

do not use this adult product in children under 12 years of age

this will provide more than the recommended dose ( overdose ) of

non aspirin and could cause health problems.
Warnings and Precautions (34071-1)
LIVER  WARNING This product contains  acetaminophen.



severe liver damage may occur if adult takes more than 6 doses in 24 hours



which is the maximum daily amount.



child takes more than 5 doses in 24 hours



which is the maximum daily amount.



taken with other drugs containing acetaminophen.



adult has 3 or more alcoholic drinks everyday while using this product.
Section 50565-1 (50565-1)

keep out of reach of children.

Section 51727-6 (51727-6)

polyvinylpyrrolidone ; pregelaatinized starch ; sodium starch glycolate ;

stearic acid.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
Acetaminophen 650 mg ;  pain reliever ; fever reducer
Section 55106-9 (55106-9)

Acetaminophen;     650 mg


Advanced Ingredient Data


Raw Label Data

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