DUAL ACTION- acetaminophen, ibuprofen tablet 
BETTER LIVING BRANDS, LLC

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716R Albertsons 21130-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mg

Drug Facts

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:

Warnings

Acetaminophen liver damage warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Acetaminophen allergy alert:may cause severe skin reactions. Symptoms may include:

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:

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:

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

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

Other information

Inactive ingredientscolloidal 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 1-800-632-6900

716R_Albertsons_IFC_72ct716R_Albertsons_IFC_18ct716R-alb-ibupara-72ct-label716R-alb-ibupara-18ct-label

DUAL ACTION 
acetaminophen, ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-716
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULE (Capsule Shaped Tablets) Size15mm
FlavorImprint Code 80
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-716-081 in 1 CARTON08/30/2023
118 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-716-751 in 1 CARTON08/30/2023
272 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21699408/30/2023
Labeler - BETTER LIVING BRANDS, LLC (009137209)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(21130-716)

Revised: 10/2023
Document Id: 06ba0236-c86a-344c-e063-6294a90ae469
Set id: f2c096bb-cfed-bfa4-e053-2995a90af2cb
Version: 3
Effective Time: 20231019
 
BETTER LIVING BRANDS, LLC