Otc - Active Ingredient
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Infants Pain And Fever (NDC 0363-6555). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
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
Do not take more than directed.
See overdose warning
■
this product does not contain directions or complete warnings for adult use.
■
shake well before using
■ mL = milliliter
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ push air out of syringe. Insert syringe tip into the bottle opening
■ flip bottle upside down. Pull yellow part of syringe to correct dose
■ 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
DOSING CHART
| Weight (lbs) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
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 2 mg
■ store between 20-25°C (68-77°F)
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Questions or comments?
Call
1-877-290-4008
* Please review the disclaimer below.