EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet

EXTRA STRENGTH ACETAMINOPHEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each caplet)

Acetaminophen 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

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.

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 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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
store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-697
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
MICA (UNII: V8A1AW0880)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE (biconvex tablets)	Size	17mm
Flavor		Imprint Code	TCL;A71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-697-43	400 in 1 BOTTLE; Type 0: Not a Combination Product	02/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/11/2022

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-697)