DUAL ACTION PAIN RELIEF- acetaminophen, ibuprofen tablet

Dual Action Pain Relief by

Drug Labeling and Warnings

Dual Action Pain Relief by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

PURPOSE

Purposes
Pain reliever
Pain reliever

INDICATIONS & USAGE

Uses
temporarily relieves minor aches and pains due to:

• headache
• toothache
• backache
• menstrual cramps
• muscular aches
• minor pain of arthritis
  

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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 INGREDIENT

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

Questions or comments? Call 1-800-910-6874

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DUAL ACTION PAIN RELIEF 
acetaminophen, ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-924
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYDEXTROSE (UNII: VH2XOU12IE)
POVIDONE (UNII: FZ989GH94E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIACETIN (UNII: XHX3C3X673)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE (Capsule shaped tablet)	Size	15mm
Flavor		Imprint Code	80
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-924-75	1 in 1 CARTON	07/11/2023
1		72 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	ANDA216994	07/11/2023

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(11673-924)