FDA Label for Mejoralito
View Indications, Usage & Precautions
Mejoralito Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Chula Vista. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient Purpose
Acetaminophen 160 mg............. Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- headache
- flu
- sore throat
- toothache
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes takes
- more than 5 doses in 24 hours. which is the maximum daily amount.
- with other drugs containing acetaminophen.
- skin reddening
- blister
- rash
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, 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 (prescnption or non-prescription). 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.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- shake well before using
- mL= millilitar
- find right dose on chart below, if possible, use weight to dose; otherwise, use age
- only use enclosed measuring syringe
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (Ib) | Age (yr) | Dose (mL) or as directed by doctor |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
Other Information
- store between 20°-25°C (68°-77°F)
- protect from freezing
- protect from light
Questions or comments?
Call toll free 619-600-5632
Monday through Fnday 9AM - 5PM EST
Inactive Ingredients
acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.
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