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| Product NDC Code | 63029-610 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Little remedies infant fever/pain reliever |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 307675 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Medtech Products 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 t his product does not contain directions or complete warnings for adult us e do not give more than directed (see overdose warning) s hake well before using find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.) only use the enclosed AccuSafe ® syringe remove cap, insert syringe to flow restrictor and invert bottle pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek) if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in any 24-hour period replace cap tightly to maintain child resistance mL =mililiter Weight (lbs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 5 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, 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 Infant Fever/Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN BENZOIC ACID CARBOXYMETHYLCELLULOSE GLYCERIN MICROCRYSTALLINE CELLULOSE SUCROSE SODIUM BENZOATE 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 Little Remedies ® INFANT FEVER+PAIN RELIEVER Acetaminophen 160 mg / 5 mL natural berry flavor 2 FL OZ (59 mL) PRINCIPAL DISPLAY PANEL Little Remedies® INFANT FEVER+PAIN RELIEVER Acetaminophen 160 mg / 5 mL natural berry flavor 2 FL OZ (59 mL)
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
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. 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 (1-800-222-1222) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 5 mL contains: sodium 6 mg store at 20-25 º C (68-77 º F) AccuSafe ® dosing device enclosed check expiration date on bottle or box before using
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- 54-8853 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.
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 your 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 (1-800-222-1222) immediately. Prompt 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