Cough and Runny Nose Childrens Plus
Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, CHLORPHENIRAMINE MALEATE 1mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-297
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.
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Pain reliever/fever reducer
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- sneezing and runny nose
- temporarily reduces fever
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
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.
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
- liver disease
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
- sedatives or tranquilizers
- the blood thinning drug warfarin
- do not exceed recommended dose (see overdose warning )
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- new symptoms occur
- redness or swelling is present
- pain or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
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 (1-800-222-1222) right away. Quick medical attention is critical for adult as well as children even if you do not notice any signs or symptoms.
- 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)|
|36-47||4-5||do not use unless directed by a doctor|
|under 36||under 4||do not use|
- store between 20-25ºC (68-77ºF). Do not refrigerate
acesulfame potassium, alcohol, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose purified water, sodium benzoate, sorbitol, xanthan gum
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AACETAMINOPHEN COMPARE TO CHILDREN'S TYLENOL® PLUS COUGH & RUNNY NOSE ACTIVE INGREDIENTS*
Pain Relief Plus
Cough & Runny Nose
ACETAMINOPHEN 160 mg PAIN RELIEVER • REVER REDUCER
CHLORPHENIRAMINE MALEATE 1 mg ANTIHISTAMINE
DEXTROMETHORPHAN HBr 5 mg COUGH SUPPRESSANT
- Sore Throat
- Runny Nose
Ages 6 to 11 Years
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose.
TAMPER EVIDENT: DO NOT USE 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
|COUGH AND RUNNY NOSE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
|Labeler - TOP CARE (Topco Associates LLC) (006935977)|
Medically reviewed on May 10, 2018
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.