Cold and Head Congestion Severe

Generic name: ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

TopCo Associates LLC

Dosage Form

N/A

Manufacturer

TopCo Associates LLC

Active ingredients

ACETAMINOPHEN325 mg
GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE5 mg

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)

for the temporary relief of the following cold symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- sinus congestion and pressure
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily reduces fever

When using this product do not exceed recommended dosage

What it looks like

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

Package codes (NDC)

36800-575-02

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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, perists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Overdose warning

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

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adults and children 12 years and over	take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Active ingredients

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.do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours childr…

Do not use if…

Ask a doctor before use if…nervousness, dizziness, or sleeplessness occur 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 come…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you are 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 between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information

Package labelNDC 36800-575-02 TopCare® Health Compare to Tylenol® Cold + Head Congestion Severe Active Ingredients† Cold + Head Congestion Severe SEVERE Acetaminophen, Phenylephrine, Guafenesin Pain Reliever/Fever Reducer, Nasal Deco…