Drug Facts
Active ingredients (in each chewable tablet)
Acteaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Mejoralito Children (NDC 69729-160). 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 drug facts, purposes, uses, warnings, do not use, ask a doctor or pharmacist before use if your child is, when using this product do not exceed recommended dosage., stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each chewable tablet)
Acteaminophen 160 mg
Pain reliever/Fever reducer
Temporarily relieves minor aches and pains due to:
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:
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.
With any other drug containing acetaminophen (prescription or nonprescription). If yu are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
taking the blood thinning drug warfarin.
Ask a doctor before use if your child has liver disease.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weigh (lb) | Age (yr) | Dose
(chewable tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 1 tablet |
| 36-47 | 4-5 | 1 1/2 tablets |
| 48-59 | 6-8 | 2 tablets |
| 60-71 | 9-10 | 2 1/2 tablets |
| 72-95 | 11 | 3 tablets |
*or as directed by a doctor
Citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminium lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose.
Call (619)600-5632 (Mon- Fri 9am - 5pm PST)
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
inov
FARMACEUTIQUE
NDC 69729-160-24
Mejoralito®
CHILDREN
Acetaminophen 160 mg
Auxiliar en el alivio del
DOLOR y FIEBRE
Pain reliever/
Fever Reducer
2-11 AÑOS/YEARS
24 Tabletas Masticables
Chewable Tablets
Sabor Uva/Grape Flavor
* Please review the disclaimer below.