Thompson Cough & Cold

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses Temporarily relieves these symptoms due to the common cold: ■ headache ■ nasal congestion ■ cough ■ minor aches and pains ■ sore throat ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive Temporarily reduces fever.

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. 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 a severe skin reactions. Symptoms may include:

■ blisters

■ rash

■ skin reddening

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.

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 have ever had an allergic reaction to this product or any of its ingredients ■ 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ difficulty in urination due to enlargement of the prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur

■ pain, cough or nasal congestion gets worse or lasts for 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets every 4 hours

■ not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 877.506.4291

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thompson

Cough & Cold

Multi-Symptom Relief

Safety Works | Business Thrives™

This Package is for Households without Young Children.

Pull to Open

Aches, Fever

Acetaminophen 325 mg

Coughs

Dextromethorphan HBr 10 mg

Chest Congestion

Guaifenesin 100 mg

Nasal Congestion

Phenylephrine HCl 5 mg

80 Caplets

Tamper Evident Sealed Packets