Acetaminophen 500 mg

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:

temporarily reduces fever

headache
muscular aches
minor pain of arthritis
backahe
the common cold
toothache
premenstrual and menstrual cramps

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

more than 4,000 mg 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

OTC - DO NOT USE SECTION

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children: (12 years and over)

Children under 12 years: Ask a doctor

do not use more than directed (see overdose warning)

OTHER SAFETY INFORMATION

Other information

store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*,purified water*, sodium starch glycolate, stearic acid*, titanium dioxide*

*may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

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Aches, Fever ● Acetaminophen 500mg

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Registered Trademark of McNeil Consumer Products

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

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Acetaminophen 500 mg

Pull To Open

This Package is For Households Without Young Children.

Pain Reliever/Fever Reducer

Compare Active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2's)

Medique Extra Strength APAP

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This Package is For Households Without Young Children

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

Compare active ingredient to Tylenol®

Registered McNeil Consumer Products

Tamper Evident Unit Dose Packets

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