TOPCARE DUAL ACTION- acetaminophen, ibuprofen tablet, film coated 
Topco Associates LLC

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Topco Associates LLC. Dual Action Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

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

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO ADVIL® DUAL ACTION ACTIVE INGREDIENTS

Dual Action

ACETAMINOPHEN 250 mg and IBUPROFEN (NSAID) 125 mg TABLETS

CONTAINS 2 MEDICINES

Acetaminophen plus Ibuprofen

PAIN RELIEVER

144 CAPLETS

CAPSULE-SHAPED TABLETS

actual size

dual action-image 1
dualaction image-2
TOPCARE DUAL ACTION 
acetaminophen, ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize14mm
FlavorImprint Code I;I
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-501-681 in 1 CARTON03/06/2023
136 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:76162-501-231 in 1 CARTON03/06/2023
272 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:76162-501-161 in 1 CARTON03/06/2023
3144 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21483603/06/2023
Labeler - Topco Associates LLC (006935977)

Revised: 3/2023
Document Id: 45a4d44d-ba32-4aec-8eaf-9665cb6fb08b
Set id: dddc04c4-d500-4d42-8406-89f27a9ad651
Version: 2
Effective Time: 20230317
 
Topco Associates LLC