ACETAMINOPHEN GELCAPS- acetaminophen tablet

Acetaminophen Gelcaps by

Drug Labeling and Warnings

Acetaminophen Gelcaps by is a Otc medication manufactured, distributed, or labeled by Kroger, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

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

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 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 SAFETY INFORMATION

Other information

• each gelcap contains: sodium 1 mg
• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
• avoid high humidity

INACTIVE INGREDIENT

Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

QUESTIONS

Questions or comments? Call 1-800-632-6900

PRINCIPAL DISPLAY PANEL

Acetaminophen 500 mg Gelcaps 24ct carton

Acetaminophen 500 mg Gelcaps 24ct Label

Acetaminophen 500 mg Gelcaps 100ct carton

Acetaminophen 500 mg Gelcaps 100ct Label

Acetaminophen 500 mg Gelcaps 225ct carton

Acetaminophen 500 mg Gelcaps 225ct label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN GELCAPS 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-673
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE (UNII: FZ989GH94E)
SILICA (UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	red (Red and Blue grey)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-673-42	1 in 1 CARTON	05/26/2025
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41226-673-01	1 in 1 CARTON	05/26/2025
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41226-673-26	1 in 1 CARTON	05/26/2025
3		225 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/26/2025

Labeler - Kroger (006999528)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(41226-673)