FDA Label for Infants Pain And Fever
View Indications, Usage & Precautions
Infants Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Kinderfarms, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily reduces fever
- temporarily relieves minor aches and pains due to
- the common cold
- flu
- headache
- sore throat
- toothache
Other
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
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product, do not exceed recommended dose (see Overdose warning).
Otc - Stop Use
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.
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. Prompt medical attention is critical 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
- only use the enclosed syringe.
Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. - remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
- pull back syringe until filled to the prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the correct dose. Slowly dispense the liquid into your child's mouth (towards inner cheek).
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
*or as directed by a doctor | ||
Weight (lb) | Age (years) | Dose (mL)* |
under 24 | under 2 | ask a doctor |
24-35 | 2-3 | 5 mL |
Other Information
- Each 5mL contains: sodium 10mg
- store between 20-25˚C (68-77˚F)
- do not refrigerate
- see bottom panel for lot number and expiration date
Inactive Ingredients
Organic agave syrup, non-GMO ascorbic acid (vitamin C), organic cherry flavor, glycerin, natural flavor, non-GMO sodium citrate
DISTRIBUTED BY: KinderFarms®
Redondo Beach, CA 90277 USA
kinderfarms.com
Questions?
[email protected]
or call 424-235-0355
Principal Display Panel - 59 Ml Carton Label
KinderMed®
Same active ingredient as
Infants' Tylenol® for Children†
For Children
Ages 2-3 yrs.
INFANTS'
PAIN & FEVER
Acetaminophen
160 mg per 5 mL Oral Suspension
Pain Reliever | Fever Reducer
Organic Cherry Flavor
NON
GMO
Project
VERIFIED
nongmoproject.org
NO DYES.
NO ARTIFICIAL FLAVORS.
NO ARTIFICIAL SWEETENERS.
SYRINGE INCLUDED
2 FL OZ (59 mL)
* Please review the disclaimer below.