RESCON GG- guaifenesin and phenylephrine hydrochloride liquid 
Capellon Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rescon GG

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 age2 teaspoonsful (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoonsful (5 mL) every 4 hours
Children 2 to under 6 years of age1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 2 years of ageAsk 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

figure-01
RESCON GG 
guaifenesin and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-044
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (WILD) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64543-044-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199903/31/2022
2NDC:64543-044-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199903/31/2022
3NDC:64543-044-0125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199903/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/199903/31/2022
Labeler - Capellon Pharmaceuticals, LLC (124568093)

Revised: 8/2023
Document Id: 03847234-ff49-d9e3-e063-6294a90a9d2a
Set id: af378f6d-d506-47b0-8044-5e184ebc5d6a
Version: 8
Effective Time: 20230822
 
Capellon Pharmaceuticals, LLC