ACETAMINOPHEN- acetaminophen 500mg tablet, film coated

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., TIME CAP LABORATORIES, INC., TIME CAP LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 500 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

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

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

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 DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

STOP USE

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.

PREGNANCY 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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• SODIUM FREE
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide

*may contain this ingredient

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen 500mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-342
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL342
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-342-74	150 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2025
2	NDC: 51316-342-32	300 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/10/2025

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES INC		037052099	manufacture(51316-342)