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| Product NDC Code | 69676-0058 | ||||
|---|---|---|---|---|---|
| Drug Name | Genexa childrens acetaminophen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 307696 | ||||
| Application Number | part343 | ||||
| Labeler Name | Genexa Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Genexa Childrens Acetaminophen
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Acetaminophen 80 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) find right dose on chart below. If possible, use weight to dose; otherwise, use age. chew tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight Age Dose † Under 24 lbs. Under 2 years Ask a doctor 24-35 lbs. 2-3 years 2 tablets 36-47 lbs. 4-5 years 3 tablets 48-59 lbs. 6-8 years 4 tablets 60-71 lbs. 9-10 years 5 tablets 72-95 lbs. 11 years 6 tablets † or as directed by a doctor
| Under 24 lbs. | Under 2 years | Ask a doctor |
| 24-35 lbs. | 2-3 years | 2 tablets |
| 36-47 lbs. | 4-5 years | 3 tablets |
| 48-59 lbs. | 6-8 years | 4 tablets |
| 60-71 lbs. | 9-10 years | 5 tablets |
| 72-95 lbs. | 11 years | 6 tablets |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic sunflower lecithin, xylitol‡ ‡ natural
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 relieves minor aches and pains due to: the common cold sore throat flu toothache headache temporarily reduces fever
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.Genexa Childrens Acetaminophen Acetaminophen GLYCERIN PALM OIL XYLITOL GUAR GUM MALTODEXTRIN GLYCERYL DIBEHENATE CALCIUM CARBONATE CITRIC ACID MONOHYDRATE STEVIA REBAUDIUNA LEAF LECITHIN, SUNFLOWER CARNAUBA WAX DEXTROSE ACACIA ACETAMINOPHEN ACETAMINOPHEN G10 LIGHT BEIGE WITH SPECKLES
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.Children's Genexa® MEDICINE MADE CLEAN Ages 2-11 Acetaminophen Chewables Pain Reliever Fever Reducer How we're different Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more! Read our label vs. Children's Tylenol® Chewables Grape* 24 Chewable Tablets 80 mg each Grape Flavor 10000-GNX_Kids-Pain-Fever_Chewable_Carton_2022_05_26 Approved
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
Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing. *This product is not manufactured or distributed by Johnson & Johnson Inc., owner of the registered trademark Children's Tylenol® Chewables Grape. Patent Pending | Distributed by: Genexa Inc. Atlanta, GA 30318 | genexa.com Made in the USA with globally sourced ingredients R-20211230 NDC 69676-0058-7
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 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each tablet contains: calcium 10 mg store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-436-3921
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 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.
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 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 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 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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children 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