Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Onessip Acetaminophen Oral Suspension Bubble Gum 5 Ml Suspension
FDA Label NDC 87078-121
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 Acetaminophen Oral Suspension Bubble Gum 5 Ml (NDC 87078-121). 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 ingredient (in each 5 ml), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- Temporarily reduces fever
- Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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
- 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.
Otc - 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
Otc - Stop Use
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosage & Administration
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- Follow the instruction given on this carton for your easy use.
Age (Years) | Dose (mL)* |
Under 2 Years | Ask a doctor |
2 to under 6 | 1 Sachet (5 mL) |
6 to 11 years | 2 Sachets (10 mL) |
*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.
mL = milliliter
Recent Major Changes
Change in Direction
Storage And Handling
Other information
- store between 20-25°C (68-77°F)
- do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredient
Inactive Ingredient
anhydrous citric acid, FD&C Red No. 40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Otc - Questions
Question or Comments?
call 1-516-675-8915
* Please review the disclaimer below.
