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| Product NDC Code | 59556-854 | ||||
|---|---|---|---|---|---|
| Drug Name | Pediacare childrens fever reducer pain reliever cherry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 307668 | ||||
| Application Number | part343 | ||||
| Labeler Name | Strides Pharma Inc | ||||
| 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. shake well before using. find right dose on chart below. If possible, use weight to determine dose; otherwise, use age. 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 and insert syringe into hole at top of bottle and turn upside down. pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back in 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 use more than 5 times in 24 hours (see overdose warning) do not give more than 5 days unless directed by a doctor replace cap tightly to maintain child resistance ml = millilitre Weight (lbs) Age (yrs) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 5 ml
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| 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 Ingredients citric acid , FD&C red no.40, flavors, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum
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.PediaCare Childrens Fever Reducer Pain Reliever Cherry Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MICROCRYSTALLINE CELLULOSE POTASSIUM SORBATE SORBITOL SUCRALOSE WATER XANTHAN GUM
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 2-3 Years PediaCare® Fever REDUCER Pain RELIEVER ACETAMINOPHEN Acetaminophen Oral Suspension 160mg/5ml Cherry Flavor 2 FL OZ (59 mL) Image image image
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.Drug Facts
Other Information store at 20-25˚C (68-77˚F) tamper evident: do not use if printed seal on bottle is broken or missing
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 1-888-474-3099 Monday – Friday 8 am – 5 pm eastern standard time PediCare.com
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. Sever 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 the child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the child has liver disease. Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage (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.
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