Daytime Cold and Flu Multi-Symptom Relief

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant 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 8 Softgels in 24 hrs, 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 is followed by fever, headache, rash, nausea, or vomiting, consult 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • 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.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

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

Other information

• store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.

Inactive ingredients

butylated hydroxyanisole, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, polyethylene glycol-400, propylene glycol, propylparaben, povidone, purified water, sorbitol

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Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788