Coldtac Plus Softgels (coldtac plus softgels (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride) capsule, liquid filled) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each Softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

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

Warnings

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 bulers
• 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.

Do not use

• 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 oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.
• If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• Liver disease
• Heart disease
• Diabetes
• High blood pressure
• Trouble urinating due to enlarged prostate gland
• Cough that occurs with too much phlegm (mucus)
• Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor 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 back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

• 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

Other Information

• Store at room temperature.

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

Questions?

Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

Made for: RRX Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Principal Display Panel

NDC 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/ Supresor de la tos

Contents/Content

10 Softgels/ Capsulas de Gel