RESCON DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid

Rescon DM by

Drug Labeling and Warnings

Rescon DM by is a Otc medication manufactured, distributed, or labeled by Capellon Pharmaceuticals, LLC, Sovereign Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Chlorpheniramine Maleate 2 mg

Dextromethorphan HBr 10 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Pseudoephedrine HCl Nasal Decongestant

Usage

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
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• nasal congestion
• temporarily restores freer breathing through the nose

Warnings

Do not use

• to sedate a child or make a child sleepy
• 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 drug.

Ask a doctor before use if you have.

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

Ask a doctor or pharmacist before use if you are

• taking any other nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

Do not exceed recommended dosage.

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor 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.

If pregnant or breast feeding

Ask a health professional before use.

Keep out of reach of children

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

Directions

Do not exceed 4 doses in a 24 hour period.

• Age: Dose
• Adults and children over 12 years of age: 2 teaspoonsful (10 mL) every 4 hours
• Children 6 to under 12 years of age: 1 teaspoonsful (5 mL) every 4 hours
• Children under 6 years of age: Ask your doctor

Other Information

• store at 20°-25°C (68°-77°F)
• tamper evident: do not use if foil seal under the cap is broken or missing
• contains less than 1 mg sodium in each 5 mL teaspoonful

Inactive Ingredients

cherry flavor, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol

Questions or Comments?

Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)

Principal Display Panel

Figure 1: 16 oz. bottle label

INGREDIENTS AND APPEARANCE

RESCON DM  
chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64543-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64543-105-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1999
2	NDC: 64543-105-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1999
3	NDC: 64543-105-01	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1999

Labeler - Capellon Pharmaceuticals, LLC (124568093)

Establishment
Name	Address	ID/FEI	Business Operations
Sovereign Pharmaceuticals, LLC		623168267	manufacture(64543-105)