ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG- acetaminophen and ibuprofen tablet, film coated 
Dr. Reddy's Labortories Inc

----------

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

Active ingredients (in each caplet)

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 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:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • 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 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, glyceryl dibehenate, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium lauryl sulfate, titanium dioxide

Questions or comments?

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

Made in India

Rev: 10/24


Principal Display Panel- Container

Acetaminophen 250 mg and
Ibuprofen 125 mg Tablets
Pain Reliever

Container

Principal Display Panel- Container 250's count

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets

Pain Reliever

Container2

Container1

carton

ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG 
acetaminophen and ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code ACI
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-052-181 in 1 CARTON02/01/2025
118 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43598-052-251 in 1 CARTON02/01/2025
2250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43598-052-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
4NDC:43598-052-14144 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
5NDC:43598-052-95250 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21824702/01/2025
Labeler - Dr. Reddy's Labortories Inc (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited918608162manufacture(43598-052) , analysis(43598-052)

Revised: 2/2025
Document Id: b01cfaef-3780-ec23-cb75-55519c8e8690
Set id: 3e65c8a3-498e-1a2a-bb76-18e28ae2c73c
Version: 4
Effective Time: 20250206
 
Dr. Reddy's Labortories Inc