Active Ingredient
Active ingredient (in each 5mL) Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer
Max Relief Junior Grape Liquid
FDA Label NDC 17856-1122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Max Relief Junior Grape (NDC 17856-1122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, warnings, ask a doctor or pharmacist before use if the child has, ask doctor or pharmacist before use if your child is, stop use and ask a doctor if, overdose warning:, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily:
- reduces fever
- the common cold
- flu
- headache
- sore throat
- toothache
relieves minor aches and pains due to:
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
- skin reddening
- blisters
- rash
- 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.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
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
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.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours.
| 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 | 3 tsp or 15 mL |
Other Information
- Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Inactive Ingredients
Anhydrous Citric Acid, Glycerin, Grape Flavor, Polyethylene Glycol 400, Purified Water, Saccharin Sodium, Sodium Benzoate, Sorbitol Solution, Sodium Citrate, Sucralose.
Questions Or Comments?
call toll-free 1-877-225-6999
Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
www.akronpharma.com
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