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| Product NDC Code | 21130-746 | ||||
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| Drug Name | Better living brands childrens fever and pain reliver |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| Application Number | M013 | ||||
| Labeler Name | BETTER LIVING BRANDS LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per 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 right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.) • Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age. • Only use with enclosed dosing cup. • If needed, repeat dose every 4 hours while symptoms last. • Do not give more than 5 times 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 (lbs) Age (yrs) Dose under 24 under 2 Ask a doctor 24-35 2- under 4 5 mL 36-47 4- under 6 7.5 mL 48-59 6- under 9 10 mL 60-71 9- under 11 12.5 mL 72-95 11- under 12 15 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, natural flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, 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 ▪ 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.better living brands childrens fever and pain reliver Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID GLYCERIN POTASSIUM SORBATE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE 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 NDC 21130-746-04 Compare to the active ingredient in Little Remedies ® Children’s Fever + Pain Reliever* Children’s Fever + Pain Reliever ACETAMINOPHEN 160 mg/ 5mL PAIN RELIEVER AND FEVER REDUCER • PARABEN FREE • DYE FREE • NO ARTIFICIAL COLOR • NO ASPIRIN OR LBUPROFEN • NO HIGH FRUCTOSE CORN SYRUP For Age 2-11 NATURAL GRAPE FLAVOR 4 FL. OZ. (118 mL) DISTRIBUTED BY: LUCERNE NORTH AMERICA LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-866-578-4935 Keep this carton for future reference on full labeling. *This product is not manufactured or distributed by Prestige Consumer trademark Little Remedies ® Children’s Fever + Pain Reliever. CHILDREN'S FEVER and PAIN RELIEVER ACETAMINOPHEN
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 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.
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 right away (1-800-222-1222). Prompt 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 or comments? 1-866-467-2748
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 • pain gets worse or lasts more than 3 days • fever 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 dose (see overdose warning)
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store at room temperature • Check expiration date on bottle or box before using • DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
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, or 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. 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 dose (see overdose warning) Stop use and ask a doctor if • new symptoms occur • pain gets worse or lasts more than 3 days • fever 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 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