Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen, USP 160 mg
Infants Pain And Fever Suspension
FDA Label NDC 58602-168
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 Infants Pain And Fever (NDC 58602-168). 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. If possible, use weight to dose; otherwise, use age.
- use only enclosed syringe designed for use with this product. Do not use any other dosing device.
- remove bottle cap and insert syringe tip through opening at top of the bottle
- tip bottle upside down and draw medicine into the syringe
- fill to dose level
- dispense liquid slowly into child’s mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
| Weight (lb) | Age (yr) | Dose (mL)* |
|---|---|---|
| * or as directed by a doctor | ||
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
Attention: use only enclosed syringe 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° to 25°C (68° to 77°F)
- do not use if shrink sleeves is broken or missing
Inactive Ingredients
butylparaben, carboxymethylcellulose sodium, citric acid anhydrous, 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 2 Fl Oz (60 Ml) Container Label
AUROHEALTH NDC 58602-168-11
INFANTS' PAIN & FEVER
Suspension Liquid
Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol, Aspirin, Ibuprofen
& Gluten Free
Dye-Free Cherry Flavor
Use ONLY enclosed syringe
2 FL OZ (60 mL) Package Label-principal Display Panel 4 Fl Oz (118 mL Bottle) (Aurophen Fig1) 
Package Label-Principal Display Panel 2 Fl Oz (60 Ml) Carton Label
NDC 58602-168-11
**Compare to Infants'
TYLENOL® Oral Suspension
active ingredient
AUROHEALTH
INFANTS'
PAIN & FEVER
Suspension Liquid
Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol Free
Aspirin Free
Ibuprofen Free
Gluten Free
Dye-Free Cherry Flavor
Use ONLY enclosed syringe
2 FL OZ (60 mL)
Package Label-principal Display Panel 2 Fl Oz (60 mL) Carton Label (Aurophen Fig2) 
* Please review the disclaimer below.
