Active Ingredient (In Each 5Ml)
Acetaminophen, 160mg
Parox
FDA Label NDC 83658-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sj Incorporation Ltd for the product Parox (NDC 83658-016). 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 5ml), inactive ingredients, purpose, uses, warnings, keep out of reach of children, do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Anhydrous citric acid, cherry flavor, glycerin,microcrystalline cellulose,carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum
Purpose
Pain reliever/fever reducer
Uses
Temporarily: • Reduces fever
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 for this product
- With other drugs containing acetaminophen
- skin reddening
- blisters
- rash.
- 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
- 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.
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
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:
Ask a doctor before use if your child hasliver disease
Ask a doctor or pharmacist before use ifyour child is taking the blood thinning drug warfarin.
When Using this product do not exceed recommended dose(see overdose warning)
Stop use and ask a doctor if
These could be signs of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children
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
Directions
- This product does not contain directions or complete warnings for adult use.
- Do not give more than directed (see overdose warning)
- Shake well before using, ml= milliliter
- Find the right dose on chart below. If possible, use weight to confirm, otherwise use age
- Remove the child protective cap and squeeze your child's dose in to the dosing cup
- Repeat dose every 4 hours while symptoms last
- Do not give more than 5 times in 24 hours or as directed by a doctor
Attention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Dosing Chart
| Weight (lbs) | Age (Years) | Dose (mL) |
| under 24 lbs | under 2 years | Ask a doctor |
| 24 -35 lbs | 2 - 3 years | 5 mL |
| 36 - 47 lbs | 4 - 5 years | 7.5 mL |
| 48 - 59 lbs | 6 - 8 years | 10 mL |
| 60 - 71 lbs | 9 -10 years | 12.5 mL |
| 72 - 95 lbs | 11 years | 15 mL |
Other Information
- Each 5 ml contains Potassium 5 mg
- Store between 20-25°C (68-77°F)
- Do not use if carton tape or bottle wrap imprinted with "PAROX" is broken or missing
Questions ?
Call +1-800-587-4041
Package Label.Principal Display Panel
INFANT'S PARXO FOR CHILDREN
ACETAMINOPHEN 160 MG PER 5 ML ORAL SUSPENSION
PAIN RELIVER/FEVER REDUCER
DYE-FREE
NDC-83658-016-01
100 ML
CHERRY FLAVOR
Carton Image (Parox)
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