Active ingredients (in each tablet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
For the temporary relief of the following cold/flu symptoms:
• minor aches and pains • headache • sore throat • nasal congestion • cough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours.
Severe liver damage may occur if you take :
• more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
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
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
• liver disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking blood thinning drug warfarin
When using this product do not exceed recommended dose
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough 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 • cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
• do not take more than directed (see overdose warning)
| adults and children 12 years and over | • take 2 tablets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 tablets in 24 hours |
| children under 12 years | ask a doctor |
Inactive ingredients
croscarmellose sodium, D&C Yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
SEE NEW WARNINGS INFORMATION & DIRECTIONS
Cold/Cough Medicine
OTC EXCELLENCE IN NUTRITIONTM
› Head & Body Aches
› Nasal Congestion
› Fever
› Sore Throat
› Cough
› Sinus Pain
READ AND KEEP CARTON FOR NEW WARNINGS INFORMATION & DIRECTIONS.
SEE ACETAMINOPHEN WARNINGS
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF BLISTER IS CUT OR BROKEN
Distributed by
OTC Pharmaceutical Products
10860 Nw 27th St , Doral , FL 33172
www.otcpharmausa.com
