MULTI-SYMPTOM NIGHTTIME COLD & FLU RELIEF SOFTGELS

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Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

Temporarily relieves common cold and flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing

Warnings

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

• more than 4 doses 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

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

• with any other product containing acetaminophen (prescription or non-prescription). 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.
• if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• 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 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 and for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• do not exceed 4 doses per 24 hours

Other information

• store at room temperature.
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Questions?

1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx

1942 NE 163rd St,

North Miami Beach, FL 33162 U.S.A.

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®NyQuil ®Cold & Flu LiquiCaps ®