Label: ACETAMINOPHEN AND IBUPROFEN tablet, film coated
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NDC Code(s):
58602-893-01,
58602-893-03,
58602-893-07,
58602-893-11, view more58602-893-14, 58602-893-21, 58602-893-29, 58602-893-35, 58602-893-40, 58602-893-41, 58602-893-44, 58602-893-46, 58602-893-49, 58602-893-51, 58602-893-61, 58602-893-62, 58602-893-65, 58602-893-73, 58602-893-78, 58602-893-79, 58602-893-80, 58602-893-82, 58602-893-84, 58602-893-85, 58602-893-88, 58602-893-94, 58602-893-95, 58602-893-96, 58602-893-99
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purposes
- Uses
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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
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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
- When using this product
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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
- you experience any of the following signs of stomach bleeding:
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Carton Label)
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 (1 x 2) Caplets)
AUROHEALTH
NDC 58602-893-61
**Compare to the active ingredients of Advil
Dual Action With Acetaminophen
CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen
Acetaminophen and Ibuprofen (NSAID)
Tablets 250 mg/125 mg
√ Headache √ Menstrual Cramps
√ Muscular Aches √ Toothache
√ Minor Pain of Arthritis
Pain Reliever
Each caplet contains Acetaminophen 250 mg
and Ibuprofen 125 mg
2 Caplets*
*Capsule-Shaped Tablets
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND IBUPROFEN
acetaminophen and ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-893 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color YELLOW (Light Yellow to Yellow) Score no score Shape CAPSULE (Biconvex) Size 15mm Flavor Imprint Code AI;II Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-893-03 1 in 1 CARTON 03/26/2024 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-893-82 1 in 1 CARTON 03/26/2024 2 18 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-893-73 1 in 1 CARTON 03/26/2024 3 20 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-893-07 1 in 1 CARTON 03/26/2024 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-893-11 1 in 1 CARTON 03/26/2024 5 36 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-893-14 1 in 1 CARTON 03/26/2024 6 50 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:58602-893-65 1 in 1 CARTON 03/26/2024 7 72 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:58602-893-21 1 in 1 CARTON 03/26/2024 8 100 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:58602-893-29 1 in 1 CARTON 03/26/2024 9 150 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:58602-893-62 216 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 11 NDC:58602-893-35 225 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 12 NDC:58602-893-44 400 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 13 NDC:58602-893-40 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 14 NDC:58602-893-88 750 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 15 NDC:58602-893-41 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2024 16 NDC:58602-893-49 1 in 1 CARTON 03/26/2024 16 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 17 NDC:58602-893-46 1 in 1 CARTON 03/26/2024 17 18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 18 NDC:58602-893-96 1 in 1 CARTON 03/26/2024 18 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 19 NDC:58602-893-01 1 in 1 CARTON 03/26/2024 19 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 20 NDC:58602-893-85 1 in 1 CARTON 03/26/2024 20 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 21 NDC:58602-893-78 1 in 1 CARTON 03/26/2024 21 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 22 NDC:58602-893-80 1 in 1 CARTON 03/26/2024 22 72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 23 NDC:58602-893-94 1 in 1 CARTON 03/26/2024 23 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 24 NDC:58602-893-51 216 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2024 25 NDC:58602-893-84 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2024 26 NDC:58602-893-99 400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2024 27 NDC:58602-893-79 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2024 28 NDC:58602-893-95 750 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2024 29 NDC:58602-893-61 1 in 1 CARTON 03/26/2024 29 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218359 03/26/2024 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-893) , MANUFACTURE(58602-893)