FDA Label for Equaline Congestion Relief

Active Ingredients (In Each Tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

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

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

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 or have trouble urinating due to an enlarged prostate gland
• •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
• •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• •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)

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

• •store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F).
• •read all warnings and directions before use. Keep carton.

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?

1-877-932-7948

Principal Display Panel

compare to Advil® Congestion Relief active ingredients

congestion relief

ibuprofen and phenylephrine hydrochloride tablets 200mg/10mg

pain reliever/fever reducer (NSAID) & nasal decongestant

NON-DROWSY relief of:

Sinus Pressure

Nasal Swelling & Congestion

Headache

CONTAINS: Ibuprofen & Phenylephrine

actual size

1 pill dosage

10 coated tablets