RESCON GG- guaifenesin and phenylephrine hydrochloride liquid

Rescon GG by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Phenylephrine HCl 5 mg

Purpose

Guaifenesin Expectorant

Phenylephrine HCl Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies

• temporarily restores freer breathing through the nose
• promotes sinus drainage
• temporarily relieves sinus congestion and pressure

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 two 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
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by excessive phlegm (mucus)

When using this product

do not exceed the recommended dosage

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 the reach of children.

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

Directions

• 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 2 to under 6 years of age: 1/2 teaspoonsful (2.5 mL) every 4 hours
• Children under 2 years of age: Ask your doctor

Do not exceed 6 doses in a 24-hour period

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

artificial flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sugar.

Questions or Comments

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

Package Label

Figure 1: 16 oz. bottle label

INGREDIENTS AND APPEARANCE

RESCON GG  
guaifenesin and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64543-044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (WILD)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64543-044-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1999
2	NDC: 64543-044-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1999
3	NDC: 64543-044-01	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)