FDA Label for Cough And Cold Xl3 Xtra

Otc - Active Ingredient

Otc - Purpose

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Antitussive

Indications & Usage

Uses Temporarily relieve: •muscular aches •headache • fever •runny nose •sneezing •itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies •nasal congestion •temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

Warnings
Liver warning

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

•more than 12 capsules 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

Do not exceed recommended dosage

Otc - Do Not Use

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 allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage • 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

Otc - Ask Doctor

Ask a doctor before use if you have •liver disease •a breathing problem such as emphysema or chronic bronchitis •glaucoma •heart disease• high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •a cough that lasts or is chronic such as occurs with asthma •a cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are •taking the blood thinning drug warfarin •taking sedatives or tranquilizers

Otc - When Using

When using this product •excitability may occur, especially in children •may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect •use caution when driving a motor vehicle or operating machinery

Otc - Stop Use

Stop use and ask a doctor if •pain gets worse or lasts more than 10 days •fever gets worse or lasts more than 3 days •new symptoms occur •redness or swelling is present •nervousness, dizziness, or sleeplessness occur •symptoms persists for more than 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions Adults and children under 12 years of age •do not take more than directed (see overdose warning) •take 2 capsule every 4 hours. •do not take more than 12 capsules in 24 hours •do not use for more than 10 days unless directed by a doctor under 12 years of age •ask a doctor

Inactive Ingredient

Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water