Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Infants Pain Reliever (NDC 70677-0117). 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 5 ml), 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.
Acetaminophen 160 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition.
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
| Weight (lb) | Age (year) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructos corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
COMPARE TO INFANTS' TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT**
Infants' Pain Reliever
Acetaminophen 160 mg per 5 mL
Oral suspension alcohol free
PAIN RELIEVER / FEVER REDUCER
Ages 2-3 years
Enhanced dosing system reduces the chance of accidental ingestion and overdose
Use Only Enclosed Syringe
CHERRY FLAVOR
fl oz (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson
6555 State Highway 161 Irving, TX 75039
* Please review the disclaimer below.