Active Ingredient
Acetaminophen 160 mg per 5 mL
The following Structured Product Label (SPL) was submitted to the FDA by Kinderfarms, Llc for the product Kinderfarms Infants Pain And Fever (NDC 82673-100). 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, purpose, uses, warnings, keep out of reach of children, overdose warning, directions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg per 5 mL
Pain Reliever / Fever Reducer
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
■ any new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts more than 5 days
■ fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep out of reach of children.
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. Prompt medical attention is critical even if you do not notice any signs or symptoms.
■ 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
■ only use the enclosed syringe.
Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
| Weight (lb) | Age (years) | Dose (mL)* |
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
*or as directed by a doctor
Organic agave syrup, non-GMO ascorbic acid (vitamin C), glycerin, organic grape flavor, natural flavors, non-GMO sodium citrate
DISTRIBUTED BY: KinderFarms
®
Redondo Beach, CA 90277 USA
kinderfarms.com
[email protected]
or call 424-235-0355
KinderFarms TM
Infants' Pain & Fever
Acetaminophen
160 mg per 5 mL
Pain Reliever | Fever Reducer
ORAL SUSPENSION
Organic Grape Flavor
FREE FROM Dyes, Artificial Flavors, Artificial Sweeteners
Non GMO Project Verified
nongmoproject.org
Syringe Included
2 FL OZ (59 mL)
* Please review the disclaimer below.