FDA.reportPublic FDA data

Mejoralito Infant Fever 2 fl oz

Manufacturer
OPMX | KJD Pharma Private Limited
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:01:52

Label at a glance#

ProductMejoralito
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use, shake well before using mL= mililiter find right dose on chart below, if possible, use weight to dose; otherwise, use age. use only the enclosed dropper designed for use with product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms lasts do not give more than 5 times in 24 hours do not give more tha...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

  • Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

  • Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

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 recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use, shake well before using
  • mL= mililiter
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age.
  • use only the enclosed dropper designed for use with product.

Do not use any other dosing device.

  • if needed, repeat dose every 4 hours while symptoms lasts
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by doctor (see overdose warning)
Weight (lbs)Age (yrs.)Dose (tsp or mL)
under 24under 2ask a doctor
24 to 352 to 31 tsp or 5 mL
36 to 474 to 51 1/2 tsp or 7.5 mL
48 to 596 to 82 tsp or 10 mL
60 to 719 to 102 1/2 tsp or 12.5 mL
72 to 95113 tsp or 15 mL

*or as directed by doctor

Other information

OTHER SAFETY INFORMATION

store at room temperature 20°-25°C (68°-77°F). Protect from Freezing. Protect from Light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, cherry flavor, glycerin, microcrystalline cellulose and sodium carboxymethyl cellulose, potassium sorbate, purified water, sorbitol, sucralose, sucrose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

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

Distributed by

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

MADE IN INDIA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PDP1PDP1

BOTTLEBOTTLE

ESPESP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860006095161GTIN-13: 0860006095161
EAN-13: 0860006095161
GTIN-12: 860006095161
UPC-A: 860006095161
GTIN storage (14 digits): 00860006095161		Mejoralito Children PDP.jpg
QR code linkQR Codeopmx.us/Mejoralito Children PDP.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-82369729-823-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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
MejoralitoACETAMINOPHENOPMX5a963a92-e29d-05ba-e063-6394a90a3a472026-09-03WarningsExact identifier
ndc (package): 69729-823-02
ndc (product): 69729-823
ndc11 (package): 69729082302
spl id: 5a963a92-e29e-05ba-e063-6394a90a3a47
spl set id: 5a963a92-e29d-05ba-e063-6394a90a3a47

Reported adverse events (FAERS/openFDA)#

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