RONDEC-D- chlophedianol hydrochloride,pseudoephedrine hydrochloride liquid

Rondec-D by

Drug Labeling and Warnings

Rondec-D by is a Otc medication manufactured, distributed, or labeled by Laser Pharmaceuticals, LLC, Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

(in each 5mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

PURPOSE

Purpose

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE

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

Warnings

Do not exceed recommended dosage.

DO NOT USE

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.

ASK DOCTOR

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION

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

Other information

Store at 59°-86°F (15°-30°C)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RONDEC-D 
chlophedianol hydrochloride,pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16477-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16477-101-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2017
2	NDC: 16477-101-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/21/2017

Labeler - Laser Pharmaceuticals, LLC (614417132)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(16477-101)