Cold and Flu Severe Daytime/Nighttime

SPL UNCLASSIFIED SECTION

DAYTIME SEVERE COLD AND FLU RELIEF

Drug Facts

OTC - PURPOSE SECTION

Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throat
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning

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

more than 8 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:

If a skin reaction occurs, stop use and seek medical help right away.

skin reddening
blisters
rash

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

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
high blood pressure
thyroid disease
diabetes
glaucoma
a sodium-restricted diet
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin; taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

Stop use and ask a doctor if

These could be signs of a serious condition.

you get nervous, dizzy or sleepless
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 rash or headache that lasts

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults & children 12 yrs and over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

take only as directed
do not exceed 8 softgels per 24 hrs

Other information

store at 20-25°C (68-77°F)
protect from light, heat and moisture

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

1-888-423-0139