FDA.reportPublic FDA data

Rondec-D

Manufacturer
Laser Pharmaceuticals, LLC | Woodfield Pharmaceutical, LLC
Effective date
2018-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:47:17

Label at a glance#

ProductRondec-D
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, CHLOPHEDIANOL HYDROCHLORIDE
Label structure15 sections

Storage and handling

Other information Store at 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

OTC - DO NOT USE SECTION

Do not use this product

  • 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.

OTC - ASK DOCTOR SECTION

Ask a physician before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - STOP USE SECTION

Stop use and ask a physician if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur

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 the reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Do not exceed recommended dosage.

Adults and children

12 years of age

and over:

2 teaspoonfuls every

6 to 8 hours, not to

exceed 8 teaspoonfuls

in a 24 hour period

Children 6 to under

12 years of age:

1 teaspoonful every

6 to 8 hours, not to

exceed 4 teaspoonfuls

in a 24 hour period

Children under

6 years of age:

Consult a physician

STORAGE AND HANDLING SECTION

Other information

Store at 59°-86°F (15°-30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

OTC - QUESTIONS SECTION

Questions? Comments?

Call 1-844-302-5227

SPL UNCLASSIFIED SECTION

LASER

Manufactured for:

Laser Pharmaceuticals, LLC

Nine North Drive, Suite 400

Alpharetta, GA 30004

1-844-302-5227

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-101-16ML - Milliliter16477-10128ff9e58-0b63-4e1b-959b-9e35c95f1a0612018-02-20

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16477-10116477-101-16, 16477-101-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB

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
c0e5f74d-49c1-c44b-e053-2995a90a05445e851b0b-c815-e3a7-e053-2991aa0aabe62021-04-26WarningsExact identifier
spl set id: 5e851b0b-c815-e3a7-e053-2991aa0aabe6

Reported adverse events (FAERS/openFDA)#

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