Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Cough And Runny Nose Suspension
FDA Label NDC 36800-297
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Cough And Runny Nose (NDC 36800-297). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- 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.
Ask A Doctor Before Use If The Child Has
- liver disease
- glaucoma
- 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 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.
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 (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.
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 |
Other Information
- store between 20-25°C (68-77°F). Do not refrigerate
Inactive Ingredients
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
Questions Or Comments?
Call toll free 1-888-425-0139
Principal Display Panel
For Ages 6 to 11 Years
ORAL SUSPENSION
Children's
Pain Relief Plus
Cough & Runny Nose
FEVER REDUCER / PAIN RELIEVER
(Acetaminophen)
ANTIHISTAMINE
(Chlorpheniramine Maleate)
COUGH SUPPRESSANT
(Dextromethorphan HBr)
Relieves
- Fever & sore throat
- Sneezing & runny nose
- Cough
Cherry Flavor
Alcohol 0.05%
FL OZ (mL)
COMPARE TO CHILDREN'S TYLENOL® PLUS COUGH & RUNNY NOSE active ingredients*
*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
Package Label
TOPCARE Children's Cough and Runny Nose Cherry Flavor
* Please review the disclaimer below.
