FLU RELIEF CHILDRENS- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hci suspension
TOP CARE (Topco Associates LLC)
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredients (in each 5 mL)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCI 2.5 mg
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- stuffy nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount
- with other drugs contaning 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
- to make a child sleepy
- 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if your child has
- liver disease
- glaucoma
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use if the child is taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not exceed recommended dose (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
- new symptoms occur
- redness or swelling is present
- pain, nasal congestion or cough gets worse or last more than 5 days
- fever gets worse or last more than 3 days
- nervousness, dizziness or sleeplessness occurs
- 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: Taking more than the recommended dose (overdose) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use.
- mL =milliliter
- shake well before using
- do not give more than 5 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- if needed, repeat dose every 4 hours while symptoms last
- find the right dose on chart below. If possible, use weight to dose: otherwise, use age.
| Weight (lb) | Age (yr) | Dose ( mL) |
| 48-95 | 6-11 | 10 mL |
| 36-47 | 4-5 | do not use unless directed by a doctor |
| under 36 | under 4 | do not use |
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum
Principal Display Panel
ORAL SUSPENSION
For Ages 6 to 11
Children's Pain Relief Plus Multi-Symptom
Flu Relief
FEVER REDUCER / PAIN RELIEVER (Acetaminophen)
ANTIHISTAMINE (Chlorpheniramine maleate)
COUGH SUPPRESSANT (Dextromethorphan HBr)
NASAL DECONGESTANT (Phenylephrine HCI)
Relieves:
- Fever & Sore Throat
- Sneezing & Running nose
- Cough
- Stufy nose
BUBBLE GUM FLAVOR
Compare to Children's Tylenol® Plus Flu active ingredients*
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Flu.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO
topcare@topco.com
| FLU RELIEF
CHILDRENS
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hci suspension |
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| Labeler - TOP CARE (Topco Associates LLC) (006935977) |