FDA Label for Non-drowsy Daytime Severe Cold Multi-symptom

Active Ingredients (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 these common cold and flu symptoms:
  • sore throat
  • cough
  • nasal congestion
  • headache
  • 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) 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
• 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 for 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

• heart disease
• liver disease
• diabetes
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• thyroid disease
• cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• high blood pressure

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

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

DAYTIME

NON-DROWSY

SEVERE
COLD
MULTI-SYMPTOM
• Acetaminophen - Pain Reliever / Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Guaifenesin- Expectorant
• Phenylephrine HCl - Nasal Decongestant

12 caplets

image description - RR