ACETAMINOPHEN DEXTROMETHORPHAN HBr & DOXYLAMINE SUCCINATE SOFTGEL

CAPSULES · J.P. BUSINESS ENTERPRISE

Dosage Form

CAPSULES

Manufacturer

J.P. BUSINESS ENTERPRISE

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

do not use more than directed
excitability may occur especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful with driving a motor vehicle or operating machinery
alcohol, sedatives and tranquilizers may increase drowsiness

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

59105-005-10

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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

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.

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.

SPL UNCLASSIFIED SECTION

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

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adults and children 12 years of age and over	swallow 2 softgels with water every 6 hours
children 4 to under 12 years of age	ask a doctor
children under 4 years of age	do not use

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.Take only as recommended—see Overdose warning. do not exceed 4 doses per 24 hours adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor…

Do not use if…Keep out of reach of children.

Ask a doctor before use 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…

Ask a doctor or pharmacist before use if…taking sedatives or tranquilizers taking the blood-thinning drug warfarin.

Stop use and talk to a doctor if…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 oxidas…

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

Package labelVALUMEDS SEE NEW WARNINGS INFORMATION Compare to the active ingredients in VICKS ® NyQUIL ®* MULTI-SYMPTOM NITE TIME COLD & FLU NIGHTTIME RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE Pain Reliever Fev…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Liver warning

Sore throat warning

Overdose warning

SPL UNCLASSIFIED SECTION

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