SINUS CONGESTION AND PAIN RELIEF - Acetaminophen, Guaifenesinand Phenylephrine HCl

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

• for the temporary relief of:
• headache
• nasal congestion
• minor aches and pains
• sinus congestion and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies
• 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

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 monomine 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 you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis,or emphysema
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

These could be signs of a serious condition

• 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
• new symptoms occur
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 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

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• read all product information before using. Keep this box for important information

Inactive ingredients

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid