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| Product NDC Code | 71399-0021 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Max relief junior |
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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 | Akron Pharma 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 this product does not contain direction or complete warnings for adult use Shake well before using ml = milliliter find right dose on chart below if possible, use weight to dose; otherwise use age use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hourswhile symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by doctor. Weight (lbs.) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 24 to 35 2 to 3 1 tsp or 5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 48 to 59 6 to 8 2 tsp or 10 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 72 to 95 11 3 tsp or 15 mL Other Information store at room temperature 15 o -30 o C (59 o -86 o F) . Protect from Freezing. Protect from light.
| under 24 | under 2 | ask a doctor |
| 24 to 35 | 2 to 3 | 1 tsp or 5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL |
| 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 72 to 95 | 11 | 3 tsp or 15 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: amydrous citric acid, bubble gum flavor, glycerin, polyethylene glycol400, punfied water, saccharin sodium, sodium benzoate, sodium citrate, sorbttol solution, 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 reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat 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.MAX relief junior Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE
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.118 237 473
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.Overdose warning. In case of overdose, get medical help or contact a Paoison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
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.
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 toll-free 1-877-225-6999. Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 www.akronpharma.com This product is not manufactured by or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Eixir.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
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. Soar throat warning: i f sore throat is severe, persists or 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. 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.
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