childrens cold and flu acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CALCIUM SULFATE, UNSPECIFIED FORM CARRAGEENAN D&C RED NO. 33 EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SUCROSE SODIUM PHOSPHATE, TRIBASIC XANTHAN GUM
Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel FOR AGES 6 to 11 YEARS CHILDREN’S cold & flu ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER CHLORPHENIRAMINE MALEATE, ANTIHISTAMINE, DEXTROMETHORPHAN HBr, COUGH SUPPRESSANT, PHENYLEPHRINE HCl, NASAL DECONGESTANT ORAL SUSPENSION FAST, EFFECTIVE RELIEF OF CHILDREN’S PAIN & FEVER Relief of: Fever Sore throat Sneezing Runny nose Cough Stuffy nose GRAPE FLAVOR Compare to the active ingredients in Children’s Tylenol® Cold + Flu 4 FL OZ (120 mL) childrens cold and flu image
- Package/Label Principal Display Panel FOR AGES 6 to 11 YEARS CHILDREN’S cold & flu ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER CHLORPHENIRAMINE MALEATE, ANTIHISTAMINE, DEXTROMETHORPHAN HBr, COUGH SUPPRESSANT, PHENYLEPHRINE HCl, NASAL DECONGESTANT ORAL SUSPENSION FAST, EFFECTIVE RELIEF OF CHILDREN’S PAIN & FEVER Relief of: Fever Sore throat Sneezing Runny nose Cough Stuffy nose GRAPE FLAVOR Compare to the active ingredients in Children’s Tylenol® Cold + Flu 4 FL OZ (120 mL) childrens cold and flu image
Overview
Uses • temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • cough • stuffy nose • sneezing and runny nose • temporarily reduces fever
Indications & Usage
Uses • temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • cough • stuffy nose • sneezing and runny nose • temporarily reduces fever
Dosage & Administration
Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL)* under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • 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. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis Ask a doctor or pharmacist before use if your child is • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • do not exceed recommended dosage (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 • nervousness, dizziness or sleeplessness occur • pain, nasal congestion 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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Purpose
Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
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. • 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. • if your child has ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product • do not exceed recommended dosage (see overdose warning) • excitability may occur, especially in children • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness
Stop Use & Ask a Doctor
Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • pain, nasal congestion 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.
Keep Out of Reach of Children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Storage & Handling
Other information • each 5 mL contains: sodium 3 mg • store at 68-77 ° F (20-25 ° C). • do not use if printed neckband is broken or missing
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