Acetaminophen by PUBLIX SUPERMARKETS, INC ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPERMARKETS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each coated tablet)

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

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

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 childreneven 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 tablets every 6 hours while symptoms last
■ do not take more than 6 tablets 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 at 20-25°C (68-77°F). See USP Controlled Room Temperature.
■ see end panel for lot number and expiration date

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal display panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-538
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
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	L;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-538-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2024
2	NDC: 41415-538-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/09/2024

Labeler - PUBLIX SUPERMARKETS, INC (006922009)