FDA Label for Maximum Strength Daytime Nighttime Cold And Flu

Otc - Active Ingredient

Active ingredients (in each softgel)
Daytime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Active ingredients (in each softgel)
Nighttime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Otc - Purpose

Purposes
Daytime Cold & Flu
Pain reliever/fever reducer

Cough suppressant
Expectorant
Nasal decongestant

Purposes
Nighttime Cold & Flu
Pain reliever/fever reducer
Cough suppressant

Antihistamine
Nasal decongestant

Indications & Usage

Uses

• temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure
cough
minor aches and pains
headache
nasal congestion
sore throat
runny nose and sneezing ( Nighttime only)
itchy, watery eyes due to hay fever ( Nighttime only)
itching of the nose or throat ( 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
• temporarily reduces fever

Warnings

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

• more than 12 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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.

Otc - Do Not Use

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.

Otc - Ask Doctor

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)
• breathing problems 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)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

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

Otc - When Using

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)

Otc - Stop Use

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
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

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 over: take 2 softgels every 4 hours
• children under 12 years of age: do not use

Other Information

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat

Inactive Ingredient

Inactive ingredients (Daytime only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Inactive ingredients (Nighttime only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Otc - Questions

Questions? call 1-877-290-4008