FDA Label for Acetaminophen Extra Strength

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

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. 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

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

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

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

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.

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.

Directions

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

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

Other Information

• store between 20° to 25°C (68° to 77°F). Avoid high humidity
• do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?

1-855-274-4122

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
Made in India

Code: TS/DRUGS/16/2014

Package Label-Principal Display Panel 500 Mg (100 Gelcaps Container Label)

FAMILY
Wellness^™

EXTRA STRENGTH
PAIN RELIEF
Acetaminophen Gelcaps
500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels

FOR ADULTS

100 GELCAPS
500 mg Each                    NDC 55319-053-21

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label) - acetaminophen fig1

Package Label-Principal Display Panel 500 Mg (100 Gelcaps Container Carton)

FAMILY
Wellness^™

COMPARE TO THE ACTIVE
INGREDIENT IN EXTRA STRENGTH
TYLENOL RAPID RELEASE GELS*

EXTRA STRENGTH
PAIN RELIEF                                                RAPID
                                                                         RELEASE
Acetaminophen Gelcaps, 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels

FOR ADULTS                                                ACTUAL SIZE

100 GELCAPS                DO NOT USE WITH OTHER MEDICINES
500 mg Each                     CONTAINING ACETAMINOPHEN                            NDC 55319-053-21

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton) - acetaminophen fig2