Extra Strength
1a00a49e-f9ff-b928-e063-6394a90a4cb5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen USP, 500 mg.
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Acetaminophen USP, 500 mg.
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
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
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
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
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
Other Information
store at 20°-25°C (68°-77°F)
avoid high humidity
see end panel for expiration date and lot number
Inactive Ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
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
Drug Facts (continued)
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
Active Ingredient (in Each Gelcap)
Acetaminophen USP, 500 mg.
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
Structured Label Content
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
Purpose
Pain reliever/fever reducer
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
Do Not Use (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
Allergy Alert: (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
Liver Warning: (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
Other Information (Other information)
store at 20°-25°C (68°-77°F)
avoid high humidity
see end panel for expiration date and lot number
Inactive Ingredients (Inactive ingredients)
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
Questions Or Comments? (Questions or comments?)
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
Stop Use and Ask A Doctor If (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
Drug Facts (continued)
These could be signs of a serious condition
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
ask a health professional before use
.
Keep Out of Reach of Children (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
Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))
Acetaminophen USP, 500 mg.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:49.041239 · Updated: 2026-03-14T23:11:40.308391