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| Product NDC Code | 68016-198 | ||||
|---|---|---|---|---|---|
| Drug Name | Junior acetaminophen ages 6-11 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, ORALLY DISINTEGRATING | ||||
| RxCUI drug identifier | 477282 | ||||
| Application Number | M013 | ||||
| Labeler Name | Chain Drug Consortium | ||||
| 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 tablet) 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) ▪ find the right dose on chart below. If possible, use weight to dose; otherwise use age. ▪ chew completely do not swallow whole ▪ repeat dose every 4 hours while symptoms last ▪ do not give more than 5 times in 24 hours Weight (lbs) Age (yr) Tablets under 24 under 2 years Ask a doctor 24-35 2-3 years 1 tablets 36-47 4-5 years 1½ tablets 48-59 60-71 72-95 6-8 years 9-10 years 11 years 2 tablets 2½ tablets 3 tablets *or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, crospovidone, D&C Red no. 30 lake, dextrose, FD&C Blue no. 1 lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch sucralose
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 ▪ flu ▪ 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.Junior Acetaminophen Ages 6-11 Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED STARCH, CORN SUCRALOSE RP160
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 COMPARE TO ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® CHEWABLES* Premier Value® Children’s Pain Reliever Chewables ACETAMINOPHEN Pain Reliever/Fever Reducer Aspirin-Free Ibuprofen-Free Grape Flavor Naturally and Artificially Flavored 24 CHEWABLES TABLETS - 160 mg each TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables. Premier Value Junior Pain Reliever 24ct
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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.
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 dosage (see overdose warning).
Storage and handling
Information about safe storage and handling of the drug product.Other information ▪ store at room temperature. Avoid high humidity. Protect from light ▪ see end flap for expiration date and lot number
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 reaction. Symptoms may include: ▪ Skin reddening ▪ Blister ▪ 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 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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick 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