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| Product NDC Code | 82673-096 | ||||
|---|---|---|---|---|---|
| Drug Name | Infants pain and fever |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 307668 | ||||
| Application Number | M013 | ||||
| Labeler Name | KinderFarms, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) Acetaminophen 160 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions this product does not contain directions or complete warnings for adult use. do not take 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 be 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 desired level. 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 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
| Weight (lb) | Age (year) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily reduces fever temporarily relieves minor aches and pains due to the common cold flu headache sore throat toothache
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Infants Pain and Fever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN AGAVE TEQUILANA JUICE WATER CITRIC ACID MONOHYDRATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel INFANTS' PAIN & FEVER For Children Ages 2-3 yrs Acetaminophen 160 mg per 5 mL Pain Reliever | Fever Reducer Oral Suspension Organic Cherry Flavor SYRINGE INCLUDED FL OZ (mL) Keep outer carton for complete warnings and product information. TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING. DISTRIBUTED BY : KinderFarms® Redondo Beach, CA 90277 USA kinderfarms.com
Package Label KINDERMED Infants' Pain & Fever Cherry Flavor Acetaminophen 160 mg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information store between 20-25ºC (68º-77ºF) do not refrigerate. see bottom panel for lot number and expiration date
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if your child has liver disease.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use with any other drug containing acetaminophen (prescription or non prescription). 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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 424-235-0355
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if 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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not exceed recommended dose (see overdose warning)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 non prescription). 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 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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API