FDA Label for Tabcin Extra Strength

Active Ingredients & Purposes

Acetaminophen 250mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Otc - Purpose

Uses

For the temporary relief of symptoms due to the common cold/ flu:

• runny nose
• sneezing
• cough due to minor bronchial irritation
• nasal congestion
• minor aches and pain
• headache
• sore throat
• and to reduce fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• 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, and 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
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When Using This Product

• do not exceed the recommended dosage
• may cause excitability, especially in children
• may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product
• use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

• nervousness, dizziness, or sleeplessness occurs
• the 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 a rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other Information

• store at room temperature 15°-30°C (59°F-86°F)
• avoid excessive heat

Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone k30, propylene glycol, propylparaben, methylparaben, sodium hydroxide, sorbitol, titanium dioxide, water

Questions Or Comments

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com