Acetaminophen 500 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

For the reduction of fever.

•headache
•toothache
•minor arthritis pain
•muscular aches
•common cold
•menstrual cramps

Warnings

SPL UNCLASSIFIED SECTION

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

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

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

•skin reddening
•blisters
•rash

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

Ask a doctor before use if you have

•liver disease

Ask a doctor or pharmacist before use if

•you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

•symptoms do not improve
•pain or fever persists or gets worse
•new symptoms occur
•redness or swelling is present

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. In case of accidental 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.

Directions

•do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

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

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

XS APAP 500 mg Label

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pull to Open

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

8 Tablets

(2 x 4)

Tamper Evident Unit Dose Packets

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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