Active Ingredient (In Each 1.6 Ml = 2 Droppersful)
Acetaminophen 160 mg
Infants Pain Reliever
FDA Label NDC 53807-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Infants Pain Reliever (NDC 53807-220). 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 1.6 ml = 2 droppersful), purpose, uses, liver warning:, sore throat warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Fever reducer/ pain reliever
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- immunizations
- toothache
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
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 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; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
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 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.
- shake well before using
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- fill to dose level. Do not use any other dosing device.
- dispense liquid slowly into child's mouth, toward inner cheek.
- if needed, repeat dose every 4 hours while symptoms last.
- do not give use than 5 times in 24 hours
- replace original bottle cap to maintain child resistance
- use only with enclosed dropper
- rinse dropper after each use
Dosing Chart
| Weight (lbs.) | Age (yrs.) | Dose ( mL) |
|---|---|---|
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 2 droppersful (0.8 + 0.8 mL) |
Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.
Other Information
- TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
- shake well before use.
- Store at room Temperature 15° - 30°C (59° - 86°F)
- protect from freezing.
Inactive Ingredients
butyl paraben, cellulose, citric acid, FD&C Blue # 1 FD&C Red # 33, glycerin, high fructose corn syrup, propylene glycol, sodium benzoate, sorbitol, water, xanthan gum
* Please review the disclaimer below.
