FDA.reportPublic FDA data

Active Ingredient(in each 5mL) Purpose

Manufacturer
OPMX LLC | Seaway Pharma
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-30 01:01:52

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL= millilitar find right dose on chart below, if possible, use weight to dose; otherwise, use age only use enclosed measuring syringe repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (Ib) Age (yr) Dose (mL) or as dir...

Storage and handling

store between 20°-25°C (68°-77°F) protect from freezing protect from light Questions or comments? Call toll free 619-600-5632 Monday through Fnday 9AM - 5PM EST

Label contents#

Full prescribing information#

Active Ingredient(in each 5mL) Purpose

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg............. Pain reliever/fever reducer

OTC - PURPOSE SECTION

Pain Reliever & Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes 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 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 (prescnption 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

SPL UNCLASSIFIED SECTION

When using this product do not exceed recommened dose (see overdose warning)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • new sympthoms 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL= millilitar
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age
  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (Ib)

Age (yr)

Dose (mL) *

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

* or as directed by doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light

Questions or comments?
Call toll free 619-600-5632
Monday through Fnday 9AM - 5PM EST

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

SPL UNCLASSIFIED SECTION

Distributed by:
OPMX, Chula Vista CA 91910

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

containerlabel-028containerlabel-028

containerlabel-047containerlabel-047

containerlabel-068containerlabel-068

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053180259GTIN-13: 0810053180259
EAN-13: 0810053180259
GTIN-12: 810053180259
UPC-A: 810053180259
GTIN storage (14 digits): 00810053180259		containerlabel-047.jpg
BarcodeEAN-130860006095161GTIN-13: 0860006095161
EAN-13: 0860006095161
GTIN-12: 860006095161
UPC-A: 860006095161
GTIN storage (14 digits): 00860006095161		containerlabel-068.jpg
QR code linkQR Codefarma-ahorro.com/containerlabel-047.jpg, containerlabel-028.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-02869729-028-02
69729-04769729-047-02
69729-06869729-068-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-08-29full-release2026-06-01 01:12:09

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3d82e9f0-27d7-054f-e063-6294a90ab5755b8a92c9-47c0-4438-a49d-b3878f7afd732025-08-29WarningsExact identifier
spl set id: 5b8a92c9-47c0-4438-a49d-b3878f7afd73
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
ndc (product): 69729-068
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
ndc (product): 69729-047

Reported adverse events (FAERS/openFDA)#

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