Guaifenesin and Pseudoephedrine Hydrochloride

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

• •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• •temporarily relieves nasal congestion due to:•common cold•hay fever•upper respiratory allergies
• •temporarily restores freer breathing through the nose
• •promotes nasal and/or sinus drainage
• •temporarily relieves sinus congestion and pressure

Warnings

OTC - DO NOT USE SECTION

Do not use 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.

Ask a doctor before use if you have

• •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 accompanied by too much phlegm (mucus)

When using this product

• •do not use more than directed

Stop use and ask a doctor if

• •you get nervous, dizzy, or sleepless
• •symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• •do not crush, chew, or break tablet
• •take with a full glass of water
• •this product can be administered without regard for timing of meals
• •adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
• •children under 12 years of age: do not use

Other information

• •Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
• •store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512