STATUSS GREEN- chlorcyclizine hydrochloride, codeine phosphate, and pseudoephedrine hydrochloride liquid 
Magna Pharmaceuticals, Inc.

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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STATUSS GREEN

Drug Facts

Active Ingredients
(in each 5 mL teaspoonful)
Purpose
Chlorcyclizine HCl 12.5 mgAntihistamine
Codeine Phosphate 9 mgAntitussive
Pseudoephedrine HCl 30 mgNasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
  • calms the cough control center and relieves coughing

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 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

Do not use this product, unless directed by a doctor, if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • chronic pulmonary disease or shortness of breath
  • children who are taking other drugs
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by fever
  • 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

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1-2 teaspoonfuls every 6-8 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 - 1 teaspoonful every 6-8 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 2 years of age:Consult a doctor

Other information

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive ingredients

Citric Acid, Lemon-Lime Flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Questions or Comments?

Call 1-888-206-5525

Manufactured for:
MAGNA
Pharmaceuticals, Inc.
Louisville, KY 40299

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 58407-0125-16

STATUSS GREEN

Antihistamine • Antitussive
• Nasal Decongestant

Each teaspoonful (5 mL) for oral administration
contains:

Chlorcyclizine HCl 12.5 mg
Codeine Phosphate 9 mg
Pseudoephedrine HCl 30 mg

LEMON-LIME FLAVOR

This bottle is not to be dispensed to consumer.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Dispense in a tight container with a
child-resistant cap.

Manufactured for:

MAGNA
Pharmaceuticals, Inc.

Accountability

Louisville, KY 40299

www.magnaweb.com

16 oz. (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

STATUSS GREEN 
chlorcyclizine hydrochloride, codeine phosphate, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-125
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P) CHLORCYCLIZINE HYDROCHLORIDE12.5 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE9 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorLEMON, LIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58407-125-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/201108/05/2013
2NDC:58407-125-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/201108/05/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/20/201108/05/2013
Labeler - Magna Pharmaceuticals, Inc. (620988360)

Revised: 1/2017
 
Magna Pharmaceuticals, Inc.