FDA Label for Only For Cold And Flu Cough Suppressant

Drug Facts

Active Ingredient (In Each Caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses:

• temporarily relieves:
     • minor aches & pains associated with a cold, the flu or a sore throat • headache • cough due to minor throat & bronchial irritation • nasal congestion • sinus congestion & pressure
• temporarily reduces fever • reduces swelling in nasal passages
• promotes nasal and/or sinus drainage • temporarily restores free breathing through the nose
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, and make coughs more productive

Warnings:

Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you take: • with other drugs containing acetaminophen
• more than 8 caplets in 24 hrs, which is the maximum daily amount for this product
• 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.
• for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
• if you have ever had an allergic reaction to this product or any of its ingredients

Do not use, ask a doctor if you have
• liver disease • heart disease • high blood pressure • thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

When using this product,
do not use more than directed

Stop use and ask a doctor if
• you get nervous, dizzy or sleepless • 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.

Keep Out Of Reach Of Children

Overdose warning: Taking more than directed can cause serious health problems. 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.

Directions:

• Do not take more than directed - See Overdose warning
• take with a full glass of water • do not exceed 8 caplets per 24 hours

adults and children 12 yrs of age & over	2 caplets with water every 4 hrs
children 4 to 12 years of age	ask a doctor
children under 4 years of age	do not use

when using other Daytime or Night time products, carefully read each label to ensure correct dosing

Other Information:

• Store at room temperature between 20-25°C (68-77°F). • Avoid excessive heat and humidity

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6, gelatin, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl povidone, purified water, sodium starch glycolate, starch, stearic acid, talc.

Questions Or Comments ?

1-833-665-9444.