Active ingredientACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Label structure10 sections
Indications and uses
• for the temporary relief of minor aches and pains associated with • headache • the common cold • toothache • muscular aches • backache • premenstrual and menstrual cramps • the minor pain from arthritis and reduces fever. • for the temporary relief of • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever.
Dosage and administration
adults and children 12 years of age and older take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. children under 12 years of age consult a doctor
Storage and handling
• tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity
• for the temporary relief of minor aches and pains associated with • headache • the common cold • toothache • muscular aches • backache • premenstrual and menstrual cramps • the minor pain from arthritis and reduces fever. • for the temporary relief of • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever.
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 tablets 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. 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.
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 the product • this product unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostrate gland • if you are taking sedatives or tranquilizers, without first consulting your doctor.
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product • 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 • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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:
DOSAGE & ADMINISTRATION SECTION
adults and children 12 years of age and older
take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor.
children under 12 years of age
consult a doctor
Other information:
STORAGE AND HANDLING SECTION
• tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity
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