Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, CHOLINE SALICYLATE
Label structure10 sections
Indications and uses
temporarily relieves nasal congestion due to common cold, hay fever, and other upper respiratory allergies ▪ nasal congestion ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ sore throat ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive
Dosage and administration
do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. use enclosed dose cup keep dosage cup with product mL = milliliters adults and children 12 years of age and over: 30mL every 4 hours children under 12 years of age: do not use
temporarily relieves nasal congestion due to common cold, hay fever, and other upper respiratory allergies
▪ nasal congestion
▪ minor aches and pains
▪ headache
▪ temporarily reduces fever
▪ sore throat
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive
Warnings
WARNINGS SECTION
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.
Allergy alert
Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
▪ hives
▪ rash
▪ shock
▪ skin reddening
▪ facial swelling
▪ asthma (wheezing)
Stomach bleeding warnings
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 non-prescription 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.
Do not use
OTC - DO NOT USE SECTION
▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer.
▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.
▪ if you have ever had an allergic reaction to this product or any of its ingredients
▪ in children under 12 years of age
Ask a doctor before use if
OTC - ASK DOCTOR SECTION
▪ stomach bleeding warning applies to you
▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease
▪ you have a cough with excessive phlegm (mucus)
▪ you have difficulty in urination due to enlargement of the prostate gland
▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
▪ you have asthma
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ under a doctor’s care for any serious condition
▪you are taking a diuretic
When using this product do not exceed recommended dosage
OTC - WHEN USING SECTION
Stop use and ask a doctor if
OTC - STOP USE SECTION
▪ an allergic reaction occurs. Seek medical help right away.
▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days
▪ fever gets worse or lasts more than 3 days
▪ redness or swelling is present
▪ new symptoms occur
▪ ringing in the ears or a loss of hearing occurs
▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
▪ nervousness, dizziness, or sleeplessness occurs
▪ 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
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use. It is especially important not to use salicylates (NSAID) 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
DOSAGE & ADMINISTRATION SECTION
do not exceed recommended dosage.
do not take more than 6 doses in any 24-hour period.
use enclosed dose cup
keep dosage cup with product
mL = milliliters
adults and children 12 years of age and over: 30mL every 4 hours
children under 12 years of age: do not use
Other information
OTHER SAFETY INFORMATION
each 30mL contains: Sodium 12 mg
tamper evident: Do not use if foil seal under cap is broken or missing.
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