Effervescent Cold Relief Tablets
Drug Facts
Active ingredients (in each effervescent tablet) Purpose
Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg . . . . . . . . . . . . . . . . . Antihistamine
Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . . . . . . . . Nasal decongestant
*Nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Uses
temporarily relieves these symptoms of the common cold:
■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache
■ minor aches and pains ■ runny nose
■ sinus congestion and pressure
WARNINGS SECTION
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. (See note below)
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
OTC - DO NOT USE SECTION
Do not use
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin
■ 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic. ■ you are taking sedatives or tranquilizers You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
■ presently taking a prescription drug.
■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
OTC - WHEN USING SECTION
When using this product
■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.
■ do not use more than directed
■ you may get drowsy
■ avoid alcoholic drinks
■ excitability may occur, especially in children
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
OTC - STOP USE SECTION
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
■ an allergic reaction occurs. Seek medical help right away.
■ pain or nasal congestion gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
■ nervousness, dizziness or sleeplessness occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
■ do not use more than directed
■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours
■ do not take more than 8 tablets in 24 hours
■ children under 12 years: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive ingredients:
acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium
benzoate, sodium bicarbonate
INDICATIONS & USAGE SECTION
Fast Relief of: Nasal Congestion, Runny Nose, Sneezing, Headache, Sinus Pain & Pressure