LIQUIBID D-R - guaifenesin and phenylephrine hydrochloride tablet, multilayer 
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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Drug Facts

Active ingredients (in each tablet)

Guaifenesin, USP                             400 mg

Phenylephrine HCl, USP                   10 mg

Purpose

Guaifenesin, USP                               Expectorant

Phenylephrine HCl, USP                   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 nasal and/or 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 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 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 too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: one tablet every 4 hours.
  • children 6 to 12 years of age: one half (1/2) tablet every 4 hours.

Other information

  • tamper evident: do not use if seal under cap is broken or missing.
  • store at 20°- 25°C (68°- 77°F)

Inactive ingredients

calcium phosphate, colloidal silicon dioxide, crospovidone polyplasdone, FD&C blue #1, magnesium stearate (veg), microcrystalline cellulose, povidone and silicified microcrystalline cellulose.

Questions or Comments?

Call (817) 595-5820

Operation Hours: Monday – Friday 8 AM – 4 PM ET

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Figure 1 Front Panel Rev. 06/2010

1b832493-figure-01

Figure 2 Rear Panel Rev. 06/2010

1b832493-figure-02

LIQUIBID D-R 
guaifenesin and phenylephrine tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-350
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
SILICON DIOXIDE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
Product Characteristics
ColorWHITE, BLUE (light) Score2 pieces
ShapeCAPSULESize22mm
FlavorImprint Code Star;LD
Contains    
Packaging
#Item CodePackage Description
1NDC:64543-350-9090 in 1 BOTTLE
2NDC:64543-350-022 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/18/2008
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 06/2010
 
Capellon Pharmaceuticals, LLC