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

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 Sun Pharmaceutical Industries, Inc., Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

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

Purposes

Pain reliever

Pain reliever

Uses

temporarily relieves minor aches and pains due to:

• headache
• toothache
• backache
• menstrual cramps
• muscular aches
• 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 tablets 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. 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 tablets every 8 hours

  while symptoms persist

• children under 12 years: ask a doctor

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

Other information

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

Inactive ingredients

colloidal silicone dioxide, croscarmellose sodium, ferric oxide yellow, ferrosoferric oxide, glyceryl dibehenate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

Call 1-866-923-4914

Distributed by:

Ohm Laboratories Inc.
New Brunswick, NJ 08901

Made in Israel

PRINCIPAL DISPLAY PANEL

NDC: 51672-4258-0

Acetaminophen 250 mg and Ibuprofen 125 mg

18 Tablets

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-4258
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
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	T;II
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-4258-4	1 in 1 CARTON	03/15/2026
1		72 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51672-4258-1	1 in 1 CARTON	03/15/2026
2		216 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA219053	03/15/2026

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	manufacture(51672-4258)