pain relief

Publix Super Markets Inc

Publix Super Markets, Inc. Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each gelcap)
• Purpose
• pain relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• pain relief Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

pain relief Uses

• •temporarily relieves minor aches and pains due to:
• •headache
• •muscular aches
• •backache
• •minor pain of arthritis
• •the common cold
• •toothache
• •premenstrual and menstrual cramps
• •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •with other drugs containing acetaminophen
• •3 or more alcoholic drinks every day while using this product

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 have ever had an allergic reaction to this product or any of its ingredients

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 use and ask a doctor if

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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.

Directions

• •do not take more than directed (see Liver warning)

take 2 gelcaps every 6 hours while symptoms last

do not take more than 6 gelcaps in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor

•

•

•

adults and children 12 years and over
children under 12 years	ask a doctor

Other information

• •store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

pain relief

ACETAMINOPHEN EXTRA STRENGTH

PAIN RELIEVER

FEVER REDUCER

for adults

ACTUAL SIZE

100 GELCAPS – 500 mg each

Compare to the active ingredient in Tylenol® Extra Strength Rapid Release Gels

pain relief Acetaminophen TABLET, COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:56062-046 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES POVIDONES STEARIC ACID titanium dioxide POLYETHYLENE GLYCOLS Product Characteristics Color Size Imprint Code Shape RED (grey top) 19 mm L046 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 in 1 BOTTLE 2 100 in 1 BOTTLE 3 NDC:56062-046-78 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part343 2011-08-29