FDA Label for Multi-symptom Daytime

Other

Drug Facts

Otc - Purpose

Active ingredients (in each softgel)                 Purposes
Acetaminophen 325 mg...............................Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg................Cough suppressant
Phenylephrine hydrochloride 5 mg.........................Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches/pains
• fever

Liver Warning

This product contains acetaminophen. Severe liver
damage may occur if you take
■ more than 10 softgels in 24 hours, which is the maximum daily
amount for this product
■ 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

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.

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.

Ask A Doctor Before Use If You Have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

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 last 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

 In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Directions

■ do not take more than the recommended dose
■ adults and children 12 years and over: take 2 softgels with water
every 4 hours. Do not exceed 10 softgels in 24 hours or as directed
by a doctor.
■ children under 12 years: do not use

Other Information

•  store at room temperature. Avoid excessive heat above 40°c (104°F).

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

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