Active Ingredient
Active ingredient (in each 5mL)
- Acetaminophen 160 mg
Mejoralito Children Syrup
FDA Label NDC 69729-825
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Mejoralito Children (NDC 69729-825). 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.
Label Section Quick Index
Purpose
Purpose
- Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- sore throat
- the common cold
- flu
- headache
- toothache
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, wich 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 (prescription or non-prescription).
- if your child is allergic to acetaminophen or any of the inactive ingredientes in this product
Ask A Doctor Before Use If Your Child Has
liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin
When Using This Product
do not exceed recomended dose (see overdose warning)
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
- this product does not contain directions or complete warnings for adult use. Shake well before using
- mL = milliliter
- find right dose or chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- only use enclosed measuring cup
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor.
† always check with your doctor before administering medicine to your infant/child
Other Information
- each teaspoon (5 mL) contains: sodium 1 mg
- Store between 15°-30° C (59°-86° F)
- Protect from Freezing and light
Inactive Ingredients
Anhydrous citric acid, carboxymethylcellulose, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Questions?
Call toll free 619-600-5632 Monday through Friday 9AM - 5 PM EST
Distributed By
VERSION EN ESPANOL EN EL INTERIOR DE LA CAJA
Exclusively distributed by:
OPMX
Chula Vista CA 91910
Phone: 619-600-5632
Manufactured in
FDA Registered Facility in the USA
Principal Display Panel
NDC 69729-825-04
Mejoralito ®
ACETAMINOPHEN
160 mg/5 mL
Oral Suspension
Quick Relief of Fever & Pain
Children 2 to 11 years
Cherry flavor
4 fl oz (118mL)
Tamper Evident: Do not use this product if the safety seal under cap is broken or missing
Mejoralito®
ACETAMINOFÉN
160 mg / 5mL
Suspension Oral
Rapido Alivio para Fiebre y Dolor
Infantil de 2 a 11 años
Sabor Cereza
4 fl oz (118 mL)
* Please review the disclaimer below.
