VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU SOFTGELS

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Drug Facts

OTC - PURPOSE SECTION

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

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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

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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

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Sore throat warning: If sore throat is severe, lasts for more than 2 days, or 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.
• to make a child sleep

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

• do not use more than directed
• 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 and tranquilizers may increase drowsiness

OTC - STOP USE SECTION

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.

Overdose warning

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

• Take only as recommended—see Overdose warning.
• do not exceed 4 doses per 24 hours adults and children 12 years of age and overswallow 2 softgels with water every 6 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not use

Other information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
• this product does not contain phenylpropanolamine

Inactive ingredients

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

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Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779