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| Product NDC Code | 63029-602 | ||||
|---|---|---|---|---|---|
| Drug Name | Little remedies childrens fever pain reliever |
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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 | Medtech Products Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Little Remedies Childrens Fever Pain Reliever
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose Warning Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.
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 give more than directed (see overdose warning). Shake well before using. Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.) Pour liquid into AccuSafe® dosing cup to the appropriate amount for your child's weight and/or age. Only use with enclosed AccuSafe® dosing cup. If needed, repeat dose every 4 hours while symptoms last. Do not give more than 5 days in any 24-hour period (see overdose warning). Do not give more than 5 days unless directed by a doctor. Replace cap tightly to maintain child resistance. Weight (lb) Age (yr) Dose Under 24 under 2 Ask a doctor 24-35 2 – under 4 5mL 36-47 4 – under 6 7.5mL 48-59 6 – under 9 10 mL 60-71 9 – under 11 12.5mL 72-95 11 – under 12 15mL
| | | |
| Under 24 | under 2 | Ask a doctor |
| 24-35 | 2 – under 4 | 5mL |
| 36-47 | 4 – under 6 | 7.5mL |
| 48-59 | 6 – under 9 | 10 mL |
| 60-71 | 9 – under 11 | 12.5mL |
| 72-95 | 11 – under 12 | 15mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, natural flavors, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, 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 relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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.Little Remedies Childrens Fever Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE GLYCERIN POTASSIUM SORBATE POVIDONE PROPYLENE GLYCOL WATER SODIUM CITRATE SUCRALOSE SUCROSE XANTHAN GUM Little Remedies Childrens Fever Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE GLYCERIN POTASSIUM SORBATE POVIDONE PROPYLENE GLYCOL WATER SODIUM CITRATE SUCRALOSE SUCROSE 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 Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL CHERRY FLAVOR 4 FL OZ (118 mL) Little Remedies Childrens Fever Cherry Carton
Principal Display Panel Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL GRAPE FLAVOR 4 FL OZ (118 mL) Little Remedies Childrens Fever Grape Carton
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 20-25ºC (68-77ºF) AccuSafe® Dosing cup enclosed. Check expiration date on bottle or box before using. Tamper Evident: DO NOT USE if printed shrink band on bottle is broken or missing.
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 the 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 products 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-754-8853 Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST LittleRemedies.com.
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 fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present 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 dosage (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 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, or is accompanied or followed by fever, headache, rash nausea or vomiting, consult a doctor promptly. Do not use with any other products 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 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 new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose Warning Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of 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