ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG- acetaminophen 250 mg and ibuprofen 125 mg tablets tablet, film coated

Acetaminophen 250 mg and Ibuprofen 125 mg by

Drug Labeling and Warnings

Acetaminophen 250 mg and Ibuprofen 125 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever

Uses

 temporarily relieves minor aches and pains due to:
o headache
o toothache
o backache
o menstrual cramps
o muscular aches
o minor pain of arthritis

Warnings

Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
 with other drugs containing acetaminophen
 more than 6 caplets in 24 hours, which is the maximum daily amount for this product
 3 or more alcoholic drinks every day while using this product

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
 skin reddening
 blisters
 rash
If skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
 hives
 facial swelling
 asthma (wheezing)
 shock
 skin reddening
 rash
 blisters
If an allergic reaction occurs, stop use and seek medical help right away.

NSAID stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
 are age 60 or older
 have had stomach ulcers or bleeding problems
 take a blood thinning (anticoagulant) or steroid drug
 take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
 have 3 or more alcoholic drinks every day while using this product 
 take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever
 right before or after heart surgery

Ask a doctor before use if

 you have liver disease
 stomach bleeding warning applies to you
 you have problems or serious side effects from taking pain relievers
 you have a history of stomach problems, such as heartburn
 you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
 you are taking a diuretic

Ask a doctor or pharmacist before use if you are

 under a doctor’s care for any serious condition
 taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
 taking any other drug

When using this product

 take with food or milk if stomach upset occurs

Stop use and ask a doctor if

 you experience any of the following signs of stomach bleeding:
o feel faint
o vomit blood
o have bloody or black stools
o have stomach pain that does not get better
 you have symptoms of heart problems or stroke:
o chest pain
o trouble breathing
o weakness in one part or side of body
o slurred speech
o leg swelling
 pain gets worse or lasts more than 10 days
 redness or swelling is present in the painful area
 any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

 do not take more than directed

• adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist
• children under 12 years: ask a doctor

  do not take more than 6 caplets in 24 hours, unless directed by a doctor

Other information

 read all warnings and directions before use. Keep carton.
 store at 20-25ºC (68-77ºF)
 avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Distributed by:

Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA

Made in India

PRINCIPAL DISPLAY PANEL

NDC: 25000-080-72

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

18 count carton label

NDC: 25000-080-72

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

18 count bottle label

 

NDC: 25000-080-07

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

90 count carton label

NDC: 25000-080-07

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

90 count bottle label

 

NDC: 25000-080-74

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

288 count bottle label

 

 

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG 
acetaminophen 250 mg and ibuprofen 125 mg tablets tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	250 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	125 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	80
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-080-72	1 in 1 CARTON	07/11/2023
1		18 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-080-07	1 in 1 CARTON	07/11/2023
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-080-74	288 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216994	07/11/2023

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-080)