DOSAGE & ADMINISTRATION SECTION.
Directions. Directions. do not take more than the recommended dose. adults and children 12 years and over: take capsules with water every hours. Do not exceed 10 capsules in 24 hours or as directed by doctor.. children under 12 years: do not use.
INACTIVE INGREDIENT SECTION.
Inactive ingredients D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide.
INDICATIONS & USAGE SECTION.
Uses. Uses temporarily relieves these symptoms due to hay fever or other upperrespiratory allergies:. runny nose sneezing. itching of the nose or throat itchy, watery eyes. temporarily relieves these symptoms due to cold:. nasal congestion sinus congestion and pressure. headache minor aches and pains cough. temporarily reduces fever.
OTHER SAFETY INFORMATION.
Other information. Other information store at room temperature. Avoid excessive heat above 40oC (104oF).
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each capsule) Acetaminophen 325 mgDextromethorphan hydrobromide 10 mgDoxylamine succinate 6.25 mgPhenylephrine hydrochloride mg.
OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers.
OTC - DO NOT USE SECTION.
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attentionis critical for adults as well as for children even if you do not notice any signs or symptoms.
OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding, ask health professional before use.
OTC - PURPOSE SECTION.
PurposesPain reliever/fever reducerCough suppressantAntihistamineNasal decongestan.
OTC - QUESTIONS SECTION.
Questions or Comments. Questions or comments 1-800-986-0369 (Mon-Fri 9AM 5PM EST).
OTC - STOP USE SECTION.
Stop use and ask doctor if. pain, cough, or nasal congestion gets worse or lasts more than days. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.. nervousness, dizziness, or sleeplessness occurs.
OTC - WHEN USING SECTION.
When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery excitability may occur, especially in children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Carton 20 count 1. Carton 20 count 2. Carton 20 count 3.
SPL UNCLASSIFIED SECTION.
WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take. more than 4,000 mg of acetaminophen in 24 hours. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:. skin reddening blisters rash hives facial swelling asthma (wheezing) shock If skin or general allergic reaction occurs, stop use and seek medical help right away.Do not use to sedate children.