Label: PAROX- children pain and fever acetaminophen 160 mg per 5ml suspension
- NDC Code(s): 83658-016-01
- Packager: SJ INCORPORATION LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each 5mL)
- Inactive Ingredients
- Purpose
-
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
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash.
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 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 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
- 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.
-
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.
- Other information
- Questions ?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAROX
children pain and fever acetaminophen 160 mg per 5ml suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83658-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 150 MPA.S AT 1%) (UNII: 99H65D77XY) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83658-016-01 1 in 1 CARTON 05/25/2024 1 100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/25/2024 Labeler - SJ INCORPORATION LTD (119051828) Registrant - SJ INCORPORATION LTD (119051828) Establishment Name Address ID/FEI Business Operations WESTCOAST PHARMACEUTICAL WORKS LIMITED 960107292 manufacture(83658-016)
