Certuss

Dosage form: tablet, multilayer
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 25mg, GUAIFENESIN 400mg
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-185

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.

Certuss

Drug Facts

Active Ingredients (per tablet)

Chlophedianol Hydrochloride       25 mg

Guaifenesin                                     400 mg

Purpose

Chlophedianol Hydrochloride       Cough Suppressant

Guaifenesin                                      Expectorant

Uses

temporarily suppresses cough impulses without narcotics.

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not use this product if:
  • you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Ask a doctor before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if
  • cough 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.
  • new symptoms occur

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
  • Adults and children 12 years of age and over: take 1 tablet every 6 to 8 hours.
  • Children 6 to under 12 years of age: take 1/2 tablet every 6 to 8 hours.
  • Children under 6: consult a doctor.
  • Do not exceed 4 doses in a 24 hour period or as directed by a doctor.

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, crospovidone polyplasdone, D&C Red #30, magnesium stearate, microcrystalline cellulose, povidone and stearic acid

Questions or Comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 90 count label

CERTUSS 
chlophedianol hcl and guaifenesin tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-185
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE25 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
D&C RED NO. 30 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STEARIC ACID 
Product Characteristics
ColorWHITE, RED (Light) Score2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code CER;REV
Contains    
Packaging
#Item CodePackage Description
1NDC:64543-185-2424 TABLET, MULTILAYER (TABLET) in 1 BOTTLE
2NDC:64543-185-9090 TABLET, MULTILAYER (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/2010
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 12/2010
 
Capellon Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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