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| Product NDC Code | 21130-223 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 313820 | ||||
| Application Number | M013 | ||||
| Labeler Name | Better Living Brands, LLC | ||||
| 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.Drug Facts Active ingredient (in each tablet) Acetaminophen USP 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) chew tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)* under 24 under 2 years ask a doctor 24 to 35 2 to 3 years 1 tablet 36 to 47 4 to 5 years 1½ tablets 48 to 59 6 to 8 years 2 tablets 60 to 71 9 to 10 years 2½ tablets 72 to 95 11 years 3 tablets *or as directed by a doctor
| under 24 | under 2 years | ask a doctor |
| 24 to 35 | 2 to 3 years | 1 tablet |
| 36 to 47 | 4 to 5 years | 1½ tablets |
| 48 to 59 | 6 to 8 years | 2 tablets |
| 60 to 71 | 9 to 10 years | 2½ tablets |
| 72 to 95 | 11 years | 3 tablets |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No. 27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, 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 sore throat toothache 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.CHILDRENS PAIN RELIEF acetaminophen ANHYDROUS CITRIC ACID SILICON DIOXIDE COPOVIDONE K25-31 CROSPOVIDONE (120 .MU.M) D&C RED NO. 27 D&C RED NO. 30 DEXTROSE MONOHYDRATE ETHYLCELLULOSE (4 MPA.S) MAGNESIUM STEARATE MANNITOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN F8
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets Blister Carton Label) Signature care ® Quality Guaranteed Compare to the Children's Tylenol ® Chewables active ingredient ** NDC 21130-223-76 AGES 2-11 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Childrens’s Pain Relief Acetaminophen Chewable Tablets 160 mg Pain Reliever/Fever Reducer • Aspirin Free • Ibuprofen Free BUBBLE GUM Flavor Actual Size 24 CHEWABLE TABLETS 160 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)
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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children 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? call 1-855-274-4122 DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O.BOX 99 PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 Made in India Code: TS/DRUGS/16/2014
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)
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light. do not use if carton is open or if printed seal on blister 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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