ShopRite Pain Relief

Wakefern Food Corporation

ShopRite Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each geltab)
• Purpose
• ShopRite 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
• ShopRite Pain Relief Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

ShopRite Pain Relief Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 geltabs (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 for more than 10 days
• •fever gets worse or lasts for 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 geltabs every 6 hours while symptoms last

do not take more than 6 geltabs 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

ShopRite Pain Relief Other information

• •store at 20–25ºC (68-77ºF)

Inactive ingredients

corn starch*,croscarmellose sodium*, D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate*, stearic acid, titanium dioxide *May contain one or more of these ingredients

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Extra Strength Tylenol®

SEE NEW WARNINGS AND DIRECTIONS

EXTRA STRENGTH – FOR ADULTS

PAIN RELIEF

Acetaminophen

Pain Reliever/Fever Reducer

actual size

100 geltabs-500 mg each

ShopRite Pain Relief Acetaminophen TABLET, COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:41190-187 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 STARCH, CORN CROSCARMELLOSE SODIUM EDETATE DISODIUM GELATIN GLYCERIN HYPROMELLOSES POLYETHYLENE GLYCOLS POVIDONES STEARIC ACID titanium dioxide water Product Characteristics Color Size Imprint Code Shape RED 10 mm L187 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 100 in 1 BOTTLE 2 NDC:41190-187-78 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part343 2013-08-14