LIQUIBID PD-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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Liquibid® PD-R

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 5 mg

Purpose

Expectorant

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 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 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

  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and older: two tablets every 4 hours
  • children 6 to 12 years of age: one tablet every 4 hours

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 tablet
  • contains 6 mg calcium in each tablet

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

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

Package Label

Figure 1: 90ct tablet bottle label

liquibid-pdr
LIQUIBID PD-R 
guaifenesin and phenylephrine hydrochloride tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64543-340
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 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, BLUEScoreno score
ShapeTRIANGLESize11mm
FlavorImprint Code Star
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64543-340-9090 in 1 BOTTLE
2NDC:64543-340-022 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/18/200812/13/2013
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(64543-340)

Revised: 2/2014
 
Capellon Pharmaceuticals, LLC