Infant's Silapap Drops

Manufacturer
Atlantic Biologicals Corps
Effective date
2016-05-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:53

Label at a glance#

ProductInfants Silapap
Active ingredientAcetaminophen
Label structure12 sections

Indications and uses

temporarily: ■ reduces fever ■ relieves minor aches and pains due to:    ■the common cold ■flu ■toothaches ■sore throat ■headaches 

Dosage and administration

■ ■ ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Repl...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

OTC - PURPOSE SECTION

Purpose: Fever reducer/pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily:

■ reduces fever

■ relieves minor aches and pains due to:    ■the common cold ■flu ■toothaches ■sore throat ■headaches 

Warnings

WARNINGS SECTION

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

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

: 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. Sore throat warning

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing acetaminophen (prescription or nonprescription). 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

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage. (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 for more than 5 days ■ fever gets worse or lasts for more than 3 days.


These could be signs of serious condition.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. Keep out of reach of children

: 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 even if you do not notice any signs or symptoms. Overdose warning

Directions

DOSAGE & ADMINISTRATION SECTION

■ ■ ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)








Weight (lb)Age (yr)
Dose (mL)
under 24
under 2 years
ask a doctor
24-35
2-3 years
 1.6 mL (0.8 + 0.8 mL)

For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Store between 20° - 25°C (68° - 77°F)

Other information

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

Comments

OTC - QUESTIONS SECTION

1-888-974-5279

Manufactured by:

Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave. Carmel , NY 10512


INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238159acetaminophen 500 MG in 5 mL Oral SolutionPSN2
238159acetaminophen 100 MG/ML Oral SolutionSCD2
238159acetaminophen 500 MG per 5 ML Oral SolutionSY2
238159acetaminophen 80 MG per 0.8 ML Oral SolutionSY2
238159APAP 100 MG/ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0145-32020-01-31C16284748780-19d75b9d0-ce38-f424-e053-dadaa90a57ceInfant's Silapap Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0145-3Infants Silapap1 mL in 1 SYRINGESOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0145INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20160505_9dacc307-0f84-4aa6-a0e6-cb99c6669bc1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-145-15ML - Milliliter54838-1453f4791e7-3734-44b4-bdec-eed360a160c412012-07-24
54838-145-30ML - Milliliter54838-145cf331cd0-d733-4230-b042-1ae69e6529e612012-07-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-014517856-0145-3
54838-145

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
393e4344-81b1-42b1-9ade-a9abee8975f79dacc307-0f84-4aa6-a0e6-cb99c6669bc12016-05-05WarningsExact identifier
spl id: 393e4344-81b1-42b1-9ade-a9abee8975f7
spl set id: 9dacc307-0f84-4aa6-a0e6-cb99c6669bc1

Reported adverse events (FAERS/openFDA)#

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