FDA Label for Day Severe Cold And Night Cold And Flu Maximum Strength

Active Ingredients (In Each Softgel)

Day Severe Cold 

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

Nighttime Cold & Flu

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes

Day Severe Cold 

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Nighttime Cold & Flu

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose and sneezing (Nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
  • controls cough to help you get to sleep (Nighttime only) 
  • temporarily reduces fever
  
  

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 12 liquid gels in 24 hours, which is the maximum daily amount
• 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Nighttime only)

When Using This Product

• do not use more than directed
• excitability may occur, especially in children (Nighttime only)
• marked drowsiness may occur (Nighttime only)
• alcohol, sedatives, and tranquilizers may increase drowsiness(Nighttime only)
• avoid alcoholic drinks (Nighttime only)
• be careful when driving a motor vehicle or operating machinery(Nighttime only)

Stop Use And Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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)
• do not take more than 12 softgels in any 24-hour period
• adults and children 12 years of age and older: take 2 softgels every 4 hours
• children under 12 years of age: do not use

Other Information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat.

Inactive Ingredients

(Daytime only) FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

(Nighttime only) D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions Or Comments?

Call toll free: 1-888-287-1915

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Maximum Strength Day and Night Severe Cold & Flu Combo 24ct

NDC 49035-586-04