Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 10 mL) Day: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Night: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Triprolidine HCl 1.25 mg
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Purpose: Day: Acetaminophen 325 mg...........Pain reliever/fever reducer Dextromethorphan HBr 10 mg................Cough suppressant Night: Acetaminophen 325 mg...........Pain reliever/fever reducer Dextromethorphan HBr 10 mg................Cough suppressant Triprolidine HCl 1.25 mg............................Antihistamine
INDICATIONS & USAGE SECTION
INDICATIONS & USAGE SECTION
Day: Uses ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help your child get to sleep ■ minor aches and pains ■ sore throat ■ headache ■ temporarily reduces fever Night: Uses ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help your child get to sleep
Warnings
WARNINGS SECTION
Day: Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 5 doses (50 mL) in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen 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, 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. ■ in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Night: Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 4 doses (40 mL) in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen 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, 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. ■ to make a child sleepy ■ in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
OTC - ASK DOCTOR SECTION
OTC - ASK DOCTOR SECTION
Day: Ask a doctor before use if the child has ■ liver disease ■ chronic cough that lasts such as occurs with asthma ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not use more than directed (see Overdose warning) Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 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 a serious condition. Night: Ask a doctor before use if the child has ■ liver disease ■ glaucoma ■ a breathing problem such as chronic bronchitis ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 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 a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of 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 even if you do not notice any signs or symptoms.
Directions
DOSAGE & ADMINISTRATION SECTION
Day: Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see Overdose warning) ■ measure only with dosing cup provided ■ do not use dosing cup with other products ■ dose as follows or as directed by a doctor ■ children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period ■ children under 6 years of age: do not use Night: Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see Overdose warning) ■ measure only with dosing cup provided ■ do not use dosing cup with other products ■ dose as follows or as directed by a doctor ■ children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 4 doses in any 24-hour period ■ children under 6 years of age: do not use
OTHER SAFETY INFORMATION
OTHER SAFETY INFORMATION
Day: Other information ■ each 10 mL contains: sodium 6 mg ■ store at 20-25ºC (68-77ºF) ■ do not refrigerate Night: Other information ■ each 10 mL contains: sodium 6 mg ■ store at 20-25ºC (68-77ºF) ■ do not refrigerate
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
Day: Inactive ingredients ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, FD&C yellow no. 10, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum Night: Inactive ingredients ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, FD&C yellow no. 10, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
OTC - QUESTIONS SECTION
OTC - QUESTIONS SECTION
Questions? 1-866-MUCINEX (1-866-682-4639)
