Cold Head Congestion Daytime

Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

American Sales Company

Dosage Form

N/A

Manufacturer

American Sales Company

Active ingredients

ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE10 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)

temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- sinus congestion and pressure
helps clear nasal passages

What it looks like

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

Package codes (NDC)

41520-603-02

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 12 caplets in 24 hours, which is the maximum daily amount
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.

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 12 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 12 caplets in 24 hours childr…

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

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°-25°C (68°-77°F) in a dry place retain carton for complete product information

Package labelCareOne® NDC 41520-603-02 COLD + HEAD CONGESTION Pain Reliever / Fever Reducer – Acetaminophen Cough Suppressant – Dextromethorphan HBr Nasal Decongestant - Phenylephrine HCl For Relief of: Headache + Body Aches Fever +…