FDA.reportPublic FDA data

Siltussin SA

Manufacturer
Atlantic Biologicals Corps
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:19:44

Label at a glance#

ProductSiltussin SA
Active ingredientGuaifenesin
Label structure8 sections

Dosage and administration

do not take more than 6 doses in any 24-hour period repeat dose every 4 hours adults and children 12 years and over 2-4 teaspoonfuls (TSP) children under 12 years DO NOT USE Store at room temperature 20°-25°C (68°-77°F). . Other information Do not accept if imprinted tamper evident safety seal around cap is broken or missing

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))

OTC - PURPOSE SECTION

Purpose: Expectorant

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive Uses

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Stop use and ask a doctor

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • repeat dose every 4 hours

adults and children 12 years and over
2-4 teaspoonfuls (TSP)
children under 12 yearsDO NOT USE

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

Do not accept if imprinted tamper evident safety seal around cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.

Questions

OTC - QUESTIONS SECTION

888-974-5279

SILTUSSIN SA (GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0117-12025-03-31C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)
17856-0117-22025-03-31C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)
17856-0117-52025-03-31C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)
17856-0117-12022-01-28C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)
17856-0117-22022-01-28C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)
17856-0117-52022-01-28C16284748780-1d6a99b39-9257-a426-e053-dadaa90af4c2Siltussin SA (Guaifenesin Liquid)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0117-1ML - Milliliter17856-0117cdbfc206-63d3-4ba8-8c27-35cdb365af1b12016-05-16
17856-0117-2ML - Milliliter17856-0117f3421a93-2c6c-4e98-9f44-debc1e97c42812016-05-16
17856-0117-5ML - Milliliter17856-01176e85a1b2-2841-447a-a981-a9ace3fbdca412016-05-16
54838-117-40ML - Milliliter54838-11767b52498-6546-4e63-a255-54d3a07968f312012-07-24
54838-117-70ML - Milliliter54838-117b9e02fd7-11f9-44a1-8caa-3f51ff5ce36d12012-07-24
54838-117-80ML - Milliliter54838-117fb019950-f868-4d0d-9450-9155bebd5a8112012-07-24

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-011717856-0117-1, 17856-0117-2, 17856-0117-5
54838-117

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
anhydrous citric acidXF417D3PSLIACT
D&C yellow no. 1035SW5USQ3GIACT
FD&C blue no. 1H3R47K3TBDIACT
FD&C red no. 40WZB9127XOAIACT
glycerinPDC6A3C0OXIACT
propylene glycol6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
sodium benzoateOJ245FE5EUIACT
sodium citrate1Q73Q2JULRIACT
sorbitol506T60A25RIACT
water059QF0KO0RIACT

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
ac983a67-c78b-4c21-9dae-357f460cd68b7b1415d8-5af2-4749-9421-22f01842e1f62020-07-30WarningsExact identifier
spl id: ac983a67-c78b-4c21-9dae-357f460cd68b
spl set id: 7b1415d8-5af2-4749-9421-22f01842e1f6

Reported adverse events (FAERS/openFDA)#

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