COLD PREPARATION FOR COUGH AND SINUS RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
New Genesis/Monticello Drug 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 15 mL)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allery alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

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

  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user has

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor if

  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough comes back or occurs, with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

 age  dose
 adults and children 12 years and over 30 mL every 4 hours 
 children 6 to 11 years  15 mL every 4 hours
 children 4 to under 6 years  ask a doctor
 children under 4 years  do not use

Other information

Inactive ingredients

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call us at 904-647-7825 or online at www.newgenesismonticellodrug.com

Principal Display Panel

*Compare to active ingredients in Vicks® DayQuil®

Cold Preparation

Acetaminophen

Pain reliever/fever reducer

Dextromethorphan hBr

Cough suppressant

Phenylephrine HCl

Nasal decongestant

For cough and sinus relief

For ages 6 and over

FL OZ (mL)

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

Distributed by: New Genesis/Monticello Drug LLC

Jacksonville, FL 32207

Package Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Monticello Cold Preparation

COLD PREPARATION  FOR COUGH AND SINUS RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11868-466
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11868-466-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 01/01/2022
2 NDC:11868-466-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 01/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/30/2015 01/01/2022
Labeler - New Genesis/Monticello Drug LLC (079396165)

Revised: 1/2016
Document Id: 332e4bc4-94fb-4632-8013-dcc8ec337280
Set id: 667abca0-4235-492b-afcd-0c9d59ee7a01
Version: 5
Effective Time: 20160105
 
New Genesis/Monticello Drug LLC