FDA Label for Daytime Nighttime

Other

Drug Facts

Otc - Active Ingredient

Daytime

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Nighttime

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

Otc - Purpose

Daytime

Pain reliever/fever reducer

Expectorant

Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Indications & Usage

Daytime

temporarily relieves these common cold and flu symptoms:

• minor aches and pains
• headache
• sore throat

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

Nighttime

temporarily relieves these common cold and flu symptoms:

• cough
• minor aches and pains
• sore throat
• headache
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever

temporarily reduces fever
controls cough to help you get to sleep

Warnings

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 12 caplets 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.

Do Not Use

Daytime

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Nighttime

• 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

Daytime

• liver disease
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Nighttime

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

Ask A Doctor Or Pharmacist Before Use

Daytime

• if you are taking the blood thinning drug warfarin

Nighttime

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When Using This Product

Daytime

• do not use more than directed

Nighttime

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

Stop Use And Ask A Doctor If

Daytime

• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

Nighttime

• pain 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.

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.

Directions

Daytime

• do not take more than directed (see Overdose warning)
• do not take more than 12 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use

Nighttime

• do not take more than directed (see Overdose warning)
• do not take more than 8 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use

Other Information

• each caplet contains: sodium 3 mg
• store at 20-25°C (68-77°F), excursion permitted between 15-30°C (59-86°F)

Inactive Ingredients Daytime

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive Ingredients Nighttime

colloidal silicon dioxide, croscarmellose sodium, hypromellose, mica, microcrystalline cellulose, povidone, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

Call 1-800-632-6900

Package Label.Principal Display Panel

ifc-20s - ifc 20s