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| Product NDC Code | 71399-0048 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Max relief junior grape |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | SUSPENSION | ||||||||
| RxCUI drug identifier | 307668 | ||||||||
| 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 Active ingredient (in each 5mL) Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer
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 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 product. Weight (lbs) Age (yrs.) Dose (tsp or mL) Weight (lbs) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 48 to 59 6 to 8 2 tsp or 10 mL 25 to 35 2 to 3 1 tsp or 5 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 72 to 95 11 2 1/2 tsp or 12.5 mL
| Weight (lbs) | Age (yrs.) | Dose (tsp or mL) | Weight (lbs) | Age (yrs.) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor | 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 25 to 35 | 2 to 3 | 1 tsp or 5 mL | 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL | 72 to 95 | 11 | 2 1/2 tsp or 12.5 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Anhydrous Citric Acid, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, 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.Ask 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)
Purpose
Information about the drug product’s indications for use.Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Spl product data elements
Usually a list of ingredients in a drug product.MAX relief junior Grape Children Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM POTASSIUM SORBATE WATER SORBITOL SUCRALOSE SUCROSE 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.4OZ 4OZ-CT 8OZ 8OZ-CT 16OZ
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 or pharmacist before use if the child has liver disease. Ask 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)
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
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 for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
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 then 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: A cetaminophen 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, persist 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. if your child is allergic to acetaminophen or anyof the inactive ingredients in this product. Ask a doctor or pharmacist before use if the child has liver disease. Ask 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 for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison 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
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