ACETAMINOPHEN 500MG- acetaminophen tablet

Acetaminophen 500mg by

Drug Labeling and Warnings

Acetaminophen 500mg by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(in each tablet)

Acetaminophen 500mg

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 the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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 the reach of children.
Overdose warning: In the 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.

KEEP OUT OF REACH OF CHILDREN

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over:
take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not take for more than 10 days unless directed by a doctor
children under 12 years:ask a doctor

Other information

store between 20-25°C (68-77°F)

Inactive Ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments? (888)788-6472

Product label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 500MG 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (Off White)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-072-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/01/2025

Labeler - Pharmaceutica North America, Inc. (962739699)