King-Tuss

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2019-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:22:35

Label at a glance#

ProductKing-Tuss SF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each 5 mL

Dextromethorphan HBr - 10 mg

Guaifenesin - 100 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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

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

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

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

DOSAGE & ADMINISTRATION SECTION

Directions: Do not exceed more than 6 doses in any 24-hour period.

 Age Dose
 Adults and children 12 years and over 2 teaspoonsfuls (10 mL) every 4 hours
 Children under 12 years Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sucralose.

OTC - QUESTIONS SECTION

Questions or comments? 1-787-692-2449

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KingTussKingTuss

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-90054859-900-04

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
cb288da6-f792-4439-943e-167750f7cc56e1ea7834-2367-4416-a3df-999e09156e522023-12-27WarningsExact identifier
spl set id: e1ea7834-2367-4416-a3df-999e09156e52

Reported adverse events (FAERS/openFDA)#

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