Drug Facts
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The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Infants Pain And Fever (NDC 41226-910). 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, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
-the common cold
-flu
-headache
-sore throat
-toothache
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.
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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.
Do not take more than directed.
See overdose warning
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.
anhydrous citric acid, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Call 1-800-632-6900
* Please review the disclaimer below.