Label: EQUALINE CONGESTION RELIEF- ibuprofen, phenylephrine hcl tablet, film coated
- NDC Code(s): 41163-158-46, 41163-158-60
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 8, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purposes
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- 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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- in children under 12 years of age because this product contains too much medication for children under this age
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
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- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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- under a doctor’s care for any serious condition
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- taking any other product that contains phenylephrine or any other nasal decongestant
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- pain gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- nasal congestion lasts for more than 7 days
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- symptoms continue or get worse
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- redness or swelling is present in the painful area
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- you get nervous, dizzy, or sleepless
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- any new symptoms appear
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Directions
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- do not take more than directed
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- adults and children 12 years of age and over:
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- take 1 tablet every 4 hours while symptoms persist.
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- do not use more than 6 tablets in any 24-hour period unless directed by a doctor
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- children under 12 years of age: do not use because this product contains too much medication for children under this age
- Other information
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Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
- Questions or comments?
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Principal Display Panel
EQUALINE®
compare to Advil® Sinus Congestion & Pain active ingredients
congestion relief
ibuprofen 200 mg
pain reliever/fever reducer (NSAID)
phenylephrine hydrochloride 10 mg
nasal decongestant tablets
sinus congestion & pain
Nasal Congestion
Headache
Sinus Pressure
Fever
Nasal Swelling
Body Aches
NON-DROWSY
actual size
20 coated tablets
ONE TABLET DOSE
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INGREDIENTS AND APPEARANCE
EQUALINE CONGESTION RELIEF
ibuprofen, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-158 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (brownish-orange) Score no score Shape OVAL Size 15mm Flavor Imprint Code L158 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-158-46 10 in 1 CARTON 07/17/2015 10/31/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41163-158-60 20 in 1 CARTON 03/08/2021 2 1 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 ANDA203200 07/17/2015 Labeler - United Natural Foods, Inc. dba UNFI (943556183)
