Active Ingredients (In Each 10 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Onessip Day Time Kids Cold And Cough Plus Fever Liquid
FDA Label NDC 87078-331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medwise Lifesciences Inc. for the product Onessip Day Time Kids Cold And Cough Plus Fever (NDC 87078-331). 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 10 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, 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
Cough suppressant
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product
- child takes more than 4 doses (10 mL each) in 24 hrs, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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 adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
- do not give more than directed (see liver warning)
- follow the instruction given on this carton for your eash use
- mL=mililiter
| Age (years) | Dose (Sachet) |
| Adults & Children 12 yrs & Over | 2 sachets (20 mL*) every 4 hrs |
| Children 6 to under 12 yrs | 1 sachet (10 mL*) every 4 hrs |
| Children 4 to under 6 yrs | ask a doctor |
| Children under 4 yrs | do not use |
Recent Major Changes
add estric mark on 10 mL
Other Information
- store between 20 - 25° C (68-77° F)
- Do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredients
citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum, edetate sodium.
Question Or Comments?
Call 1-516-675-8915
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