Label: COLD PREPARATION FOR COUGH AND SINUS RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
- NDC Code(s): 11868-466-08, 11868-466-12
- Packager: New Genesis/Monticello Drug LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 5, 2016
If you are a consumer or patient please visit this version.
- Active ingredients (in each 15 mL)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (180 mL) in 24 hours for adults
- more than 5 doses ( 75 mL) in 24 hours for children 6-12 years old
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Allery alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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
- 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
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.
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.
- do not take more than directed (see overdose warning)
- do not exceed 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
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
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
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®
Pain reliever/fever reducer
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
INGREDIENTS AND APPEARANCE
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)