Childrens Silapap

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:58

Label at a glance#

ProductChildrens Silapap
Active ingredientACETAMINOPHEN
Label structure8 sections

Dosage and administration

do not take more than directed (see overdose warning). if needed, repeat dose every 4 hours or as directed by a doctor do not give more than 5 doses in 24 hours  children under 2 yrs (under 24 lbs)  ask a doctor  children 2-3 years (24-35 lbs)  1 teaspoonful (TSP)(5 mL)  children 4-5 years (36-47 lbs)  1 1/2 teaspoonfuls (TSP)(7.5 mL)  children 6-8 years (48-59 lbs)  2 teaspoonfuls (TSP)(10 mL)  children 9-10 year...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))

OTC - PURPOSE SECTION

Purpose: Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses To reduce fever and for the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Alcohol warning:If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

OTC - DO NOT USE SECTION

Do not use

  • with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user is allergic to acetaminophen or any of the inactive ingredients in this product

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dose (see overdose warning)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 a serious condition

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning).
  • if needed, repeat dose every 4 hours or as directed by a doctor
  • do not give more than 5 doses in 24 hours

 children under 2 yrs (under 24 lbs)
 ask a doctor
 children 2-3 years (24-35 lbs)
 1 teaspoonful (TSP)(5 mL)
 children 4-5 years (36-47 lbs)
 1 1/2 teaspoonfuls (TSP)(7.5 mL)
 children 6-8 years (48-59 lbs)
 2 teaspoonfuls (TSP)(10 mL)
 children 9-10 years (60-71 lbs)
 2 1/2 teaspoonfuls (TSP)(12.5 mL)
 children 11 years (72-95 lbs)
 3 teaspoonfuls (TSP)(15 mL)
 adults & children 12 years & older
 4 teaspoonfuls (TSP)(20 mL)

Other information
Store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.

Questions

OTC - QUESTIONS SECTION

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PLACE 

MIAMI, FL  33179

ACETAMINOPHEN (SILAPAP)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN2
307675acetaminophen 32 MG/ML Oral SolutionSCD2
307675acetaminophen 160 MG per 5 ML Oral SolutionSY2
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY2
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY2
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY2
307675APAP 32 MG/ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0141-1Childrens Silapap20.31 mL in 1 CUP, UNIT-DOSELIQUID20.312
17856-0141-1Childrens Silapap50 in 1 BOX, UNIT-DOSELIQUID502
17856-0141-2Childrens Silapap50 in 1 BOX, UNIT-DOSELIQUID502
17856-0141-2Childrens Silapap31.25 mL in 1 CUP, UNIT-DOSELIQUID31.252
17856-0141-3Childrens Silapap50 in 1 BOX, UNIT-DOSELIQUID502
17856-0141-3Childrens Silapap15.6 mL in 1 CUP, UNIT-DOSELIQUID15.62
17856-0141-4Childrens Silapap2.5 mL in 1 SYRINGELIQUID2.52
17856-0141-4Childrens Silapap120 in 1 BOX, UNIT-DOSELIQUID1202
17856-0141-5Childrens Silapap72 in 1 BOX, UNIT-DOSELIQUID722
17856-0141-5Childrens Silapap5 mL in 1 CUP, UNIT-DOSELIQUID52
17856-0141-6Childrens Silapap5 mL in 1 SYRINGELIQUID52
17856-0141-6Childrens Silapap48 in 1 BOX, UNIT-DOSELIQUID482
17856-0141-7Childrens Silapap1.25 mL in 1 SYRINGELIQUID1.252
17856-0141-7Childrens Silapap120 in 1 BOX, UNIT-DOSELIQUID1202
17856-0141-8Childrens Silapap120 in 1 BOX, UNIT-DOSELIQUID1202
17856-0141-8Childrens Silapap2.5 mL in 1 SYRINGELIQUID2.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0141CHILDRENS SILAPAP (ACETAMINOPHEN) LIQUID [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 16 package rows20210116_2d17a7a6-6b15-4281-a64c-04cb5eb0daaf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-144-40ML - Milliliter54838-144e59a7e7e-4ebe-41a6-ab02-231dbfdc8fd912012-07-24
54838-144-70ML - Milliliter54838-1448d2545d1-410f-4db7-9249-6bd1ee3191c312012-07-24
54838-144-80ML - Milliliter54838-1442aca2f2c-02d1-4c54-b6d3-9fbfc7e8b49812012-07-24

Products#

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

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

NDC Codes#

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
c6f3a706-ca2a-4114-8ad3-ea3ad911d0002d17a7a6-6b15-4281-a64c-04cb5eb0daaf2021-01-15WarningsExact identifier
spl id: c6f3a706-ca2a-4114-8ad3-ea3ad911d000
spl set id: 2d17a7a6-6b15-4281-a64c-04cb5eb0daaf

Reported adverse events (FAERS/openFDA)#

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