Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen, USP 160 mg
Childrens Pain And Fever Suspension
FDA Label NDC 58602-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Childrens Pain And Fever (NDC 58602-164). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, 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
- 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.
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.
Ask A Doctor Before Use If Your Child Has
liver disease
Ask A Doctor Or Pharmacist Before Use If Your 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.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child’s dose into 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 | ||
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
- each 5 mL contains: sodium 6 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
butylparaben, carboxymethylcellulose sodium, citric acid anhydrous, D&C red no #33, FD&C red no #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum
Questions or comments? 1-855-274-4122
Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Package Label-Principal Display Panel 4 Fl Oz (118 Ml) Container Label
AUROHEALTH
NDC 58602-164-24
AGES 2-11 YEARS
Children's
PAIN & FEVER
Suspension Liquid
Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol, Aspirin, Ibuprofen
&Gluten Free
Bubble Gum Flavor
Use ONLY enclosed
dosage cup
4FL OZ (118 mL)
Package Label-principal Display Panel 4 Fl Oz (118 M L) Container Label (Acetaminophen Fig1)
Package Label-Principal Display Panel 4 Fl Oz (118 Ml) Carton Label
NDC 58602-164-24 Package Label-principal Display Panel 4 Fl Oz (118 M L) Carton Label (Acetaminophen Fig2)
**Compare to Children's
TYLENOL®Oral Suspension
active ingredient
AUROHEALTH
AGES 2-11 YEARS
Children's
PAIN & FEVER
Suspension Liquid
Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol Free
Aspirin Free
Ibuprofen Free
Gluten Free
Bubble Gum Flavor
Use ONLY enclosed
dosage cup
4FL OZ (118 mL) 
* Please review the disclaimer below.
