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ConRx Cold by Eagle Distributors,Inc.

Dosage form: tablet
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: Eagle Distributors,Inc.
NDC Code: 68737-227

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.

ConRx Cold

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325mg

Dextromethorphan HBr 10 mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/ fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Uses
  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.
    These could be signs of serious conditions.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • Do not take more than directed
Adults and Children 12 years and over
  • Take 2 tablets with water every 6-8 hours as needed
  • Do not take more than 8 tablets in 24 hour
Children under 12 years of ageConsult a doctor

Other Information
  • Do not use if pouch is torn or damaged.
  • Store between 20-25°C (68-77°F). Avoid excessive heat and humidity.
  • See side panel for lot number and expiration date.

Inactive ingredients

Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, D & C yellow #10 aluminium lake ,Titanium Dioxide.

Product manufactured for:
Eagle Distributors, Inc.
Los Angeles, CA 90011

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

NDC: 68737-227-11

Compare to the Active Ingredients in
Tylenol ® Cold
Head Congestion*

ConRx
COLD
SEVERE Sore throat -Cough - Headache

  • Acetaminophen                          Sore throat
  • Dextromethorphan HBr             Cough
  • Guaifenesin                                 Chest Congestion
  • Phenylephrine HCl                     Nasal Congestion

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
Tylenol
®Cold
Head Congestion*

50 Pouches of 2 Caplets Each

CONRX   COLD
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-227
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
EDETATE DISODIUM 
BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATE 
STARCH, CORN 
POVIDONE K90 
GELATIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 6000 
SODIUM BENZOATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
D&C YELLOW No. 10 
ALUMINUM OXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68737-227-1150 POUCH in 1 BOX
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/10/2012
Labeler - Eagle Distributors,Inc. (929837425)

Revised: 07/2012
 
Eagle Distributors,Inc.

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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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