Non-Drowsy DAYTIME COLD & FLU MULTI-SYMPTOM
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
Active ingredients (in each softgel) PurposesAcetaminophen 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
Warnings
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 SECTION
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 SECTION
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
These could be signs of a serious condition.
- 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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, lecithin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide