Severe Sinus Congestion and Pain (severe sinus congestion and pain (acetaminophen, guaifenesin, phenylephrine) tablet, coated) Dailymed

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Expectorant Nasal decongestant

Uses

• temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: • sinus congestion and pressure • headache • nasal congestion • minor aches and pains • 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 caplets (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 • bulers • rash If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use Section

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.

Otc - Ask Doctor Section

Ask a doctor before use if you have

• liver disease • heart 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)

Otc - Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Otc - When Using Section

When using this productdo not exceed recommended dose

Otc - Stop Use Section

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.

Otc - Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see OVERDOSE WARNING)

adults and children 12 years and over	• take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Other Information

• store between 20-25° C (68-77° F)

Questions Or Comments?

1-800-373-6981 (toll-free)

Inactive Ingredients

croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide

Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788

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Compare to the active ingredients in Tylenol® Sinus Severe

Severe Sinus Congestion & Pain Acetaminophen, Guaifenesin, Phenylephrine HCl

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