FDA.reportPublic FDA data

Mejoralito Children

Manufacturer
OPMX LLC
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-09 01:01:11

Label at a glance#

ProductMejoralito Children
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily: reduces fever relieves minor aches and pains due to: sore throat the common cold flu headache toothache

Dosage and administration

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 befor...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5mL)

  • Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Purpose

  • Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • sore throat
  • the common cold
  • flu
  • headache
  • toothache

Warnings

WARNINGS SECTION

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


Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blister
  • rash

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recomended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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.

Directions for useDirections for use

† always check with your doctor before administering medicine to your infant/child

Other information

OTHER SAFETY INFORMATION

  • each teaspoon (5 mL) contains: sodium 1 mg
  • Store between 15°-30° C (59°-86° F)
  • Protect from Freezing and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, carboxymethylcellulose, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

Call toll free 619-600-5632 Monday through Friday 9AM - 5 PM EST

Distributed by

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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)

PDP1PDP1

Drug Facts EspDrug Facts Esp

BOTTLEBOTTLE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850043169031GTIN-13: 0850043169031
EAN-13: 0850043169031
GTIN-12: 850043169031
UPC-A: 850043169031
GTIN storage (14 digits): 00850043169031		Mejoralito PDP.jpg
QR code linkQR Codeopmx.us/Mejoralito Bottle.jpg, Mejoralito PDP.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-82569729-825-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL SOLUTION8KW3E207O2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-16monthly-update2026-07-17 21:34:34

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5464188d-0138-033e-e063-6294a90ace665464188d-0137-033e-e063-6294a90ace662026-06-16WarningsExact identifier
spl set id: 5464188d-0137-033e-e063-6294a90ace66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.