Active Ingredient
Active ingredient (in each 5 mL)
- Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx for the product Mejoralito (NDC 69729-823). 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, purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each 5 mL)
temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
Do not use any other dosing device.
| 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 |
*or as directed by doctor
store at room temperature 20°-25°C (68°-77°F). Protect from Freezing. Protect from Light.
anhydrous citric acid, cherry flavor, glycerin, microcrystalline cellulose and sodium carboxymethyl cellulose, potassium sorbate, purified water, sorbitol, sucralose, sucrose, xanthan gum.
Call toll free 619-600-5632 Monday through Friday 9AM - 5 PM EST Monday through Friday 9AM - 5PM EST
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
MADE IN INDIA
NDC 69729-823-02
Mejoralito®
Pediatric Acetaminophen
SUSPENSION
From 2 years to 3 years
Quickly relieves fever and pain
Dye Free
Paraben Free
Cherry Flavor
SUSPENSION
2 fl oz (60 mL)
Mejoralito®
Acetaminofen Pediatrico
SUSPENSION
De 2 años a 3 años
Alivio rapido para la fiebre y el dolor
Libre de Colorantes
Libre de Parabenos
Sbor Cereza
SUSPENSION
2 fl oz (60 mL)
* Please review the disclaimer below.