Nitecin Night-Time Relief

OPMX LLC

Dosage Form

N/A

Manufacturer

OPMX LLC

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 & bronchial irritation
Sore throat
Headache
Minor aches & pains
Fever
Runny nose & sneezing

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

What it looks like

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

Package codes (NDC)

69729-054-10

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 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

SPL UNCLASSIFIED SECTION

Made for:

RRX

Exclusively distributed by:

OPMX
Chula Vista, CA 91910

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Adults & children 12 yrs & over	2 softgels with water every 6 hrs
Children 4 to under 12 yrs	Ask a doctor
Children under 4 yrs	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 directed Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 2 softgels with water every 6 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use

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 oxid…

Storage and handlingStore at room temperature

Package labelNDC 69729-054-10 Cough & Flu/ Tos y Gripe Nitecin Night-ttmeRelief Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Headache/ Dolor de cabeza Fever/ Fiebre Sore Throat/ Dolor de Garganta Sne…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Liver warning

Allergy Alert

Sore throat warning

Overdose warning

SPL UNCLASSIFIED SECTION

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