1. Home
  2. Labeler Index
  3. Puracap Pharmaceutical Llc
  4. 51013-141
  5. Label Information: Ddm Day Time And Nite Time Cold And Flu

FDA Label for Ddm Day Time And Nite Time Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THESE PRODUCTS
    8. STOP USE AND ASK A DOCTOR IF
    9. OVERDOSE WARNING:
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPLE DISPLAY PANEL

Ddm Day Time And Nite Time Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Softgel)



Active ingredients for Nighttime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purposes



DDM NITE TIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant 

Antihistamine

DDM DAY TIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant


Uses



temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing (Nighttime only)
  • nasal congestion (Daytime only)

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. 
  • to make a child sleep (Nighttime only)

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • high blood pressure (Daytime only)
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Nighttime only)

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking sedatives or tranquilizers (Nighttime only)
  • taking the blood thinning drug warfarin

When Using These Products



  • do not use more than directed

    • In addition, when using Nighttime:

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If



  • you get nervous, dizzy, or sleepless (Daytime only)
  • pain, cough or nasal congestion (Daytime only) gets worse or last more than 7 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough comes back, or occurs with rash, or headache that lasts.

    • These could be signs of a serious condition.


Overdose Warning:



Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • take only as directed - see Overdose warning
  • Take Nighttime or Daytime
  • do not exceed 4 doses per 24 hrs         
    • AgeDaytime Nighttime
     adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs
     children 4 to under 12 yrs ask a doctor ask a doctor
     children under 4 yrs do not usedo not use

    • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other Information



  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients



Daytime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink

Nighttime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink 


Questions Or Comments?



Call toll free: 1-800-833-6278


Principle Display Panel



DDM DAT TIME and NITE TIME COLD/FLU LIQUID CAPS

NDC 51013-141-08

*Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps®


* Please review the disclaimer below.