Coldtac Plus Softgels

Generic name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

OPMX LLC.

Dosage Form

N/A

Manufacturer

OPMX LLC.

Active ingredients

DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN325 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 common cold/flu symptoms:

Nasal congestion
Cough due to minor throat & bronchial irritation
Sore throat
Headache
Minor aches & pains
Fever

do not use more than directed.

What it looks like

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

Package codes (NDC)

69729-120-10

Full prescribing information (for healthcare professionals)

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. Symtoms 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Overdose warning

Taking more than directed 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 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

Phone: 619-600-5632

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Adults & children 12 yrs & over	2 softgels with water every 4 hrs
Children 4 to under 12 yrs	Ask a doctor
Children under 4 yrs	Do not use

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.Take only as directed. Do not exceed 4 doses per 24 hrs. Adults & children 12 yrs & over 2 softgels with water every 4 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…You get nervouz, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms occur. Cough comes b…

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 at room temperature.

Package labelNDC 69729-120-10 Coldtac Plus Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5mg Pain reliever, fever reducer/ Fiebre y cuerpo cortado Nasal Descongestant/ Descongestivo nasal Cough Suppressant/ Supres…