Equaline congestion relief
Ibuprofen, phenylephrine HCl · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug
Purpose
Purposes Pain reliever/fever reducer Nasal decongestant
Uses
Uses
• temporarily relieves these symptoms associated with the common cold or flu:
• headache
• fever
• sinus pressure
• nasal congestion
• minor body aches and pains
• reduces swelling of the nasal passages
• temporarily restores freer breathing through the nose
Warnings
Warnings 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. 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
• in children under 12 years of age because this product contains too much medication for children under this age
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• 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
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• 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
• 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 any other product that contains phenylephrine or any other nasal decongestant
• 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 7 days
• fever gets worse or lasts more than 3 days
• nasal congestion lasts for more than 7 days
• symptoms continue or get worse
• redness or swelling is present in the painful area
• you get nervous, dizzy, or sleepless
• any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of 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).
Do not use
Do not use
• in children under 12 years of age because this product contains too much medication for children under this age
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• 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
Ask a doctor before use if
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• 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
• you are taking a diuretic
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking any other product that contains phenylephrine or any other nasal decongestant
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug
When using this product
When using this product
• take with food or milk if stomach upset occurs
Stop use and ask a doctor
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 7 days
• fever gets worse or lasts more than 3 days
• nasal congestion lasts for more than 7 days
• symptoms continue or get worse
• redness or swelling is present in the painful area
• you get nervous, dizzy, or sleepless
• any new symptoms appear
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of 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
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).
Directions
Directions
• do not take more than directed
• adults and children 12 years of age and over:
• take 1 tablet every 4 hours while symptoms persist.
• do not use more than 6 tablets in any 24-hour period unless directed by a doctor
• children under 12 years of age: do not use because this product contains too much medication for children under this age
Other information
Other information
• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
• read all warnings and directions before use. Keep carton.
Inactive ingredients
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?
Questions or comments? 1-855-423-2630
Label text from the FDA structured product label by United Natural Foods, Inc. dba UNFI (revised Aug 8, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ibuprofen in 1 product
- Phenylephrine Hydrochloride in 1 product
Equaline congestion relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 41163-158 | Ibuprofen 200 mg/1; Phenylephrine Hydrochloride 10 mg/1 Tablet, Film Coated | United Natural Foods, Inc. dba UNFI | ANDA |
Frequently asked questions
What is Equaline congestion relief used for?
Uses • temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
Who makes Equaline congestion relief?
Equaline congestion relief is listed by 1 labeler in the FDA NDC directory, including United Natural Foods, Inc. dba UNFI.