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  5. Label Information: Nite-time Cold/flu Original

FDA Label for Nite-time Cold/flu Original

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. PREGNANT OR BREAST-FEEDING
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. DO NOT USE
    16. PRODUCT LABEL

Nite-time Cold/flu Original Product Label

The following document was submitted to the FDA by the labeler of this product Salado Sales, Inc.. 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.

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)




Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  


Purpose




Pain reliever/fever reducer  

Cough suppressant  

Antihistamine  


Keep Out Of Reach Of Children



Keep out of reach of children.


Uses



 temporarily relieves cold/flu symptoms:

  • sore throat
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation
  • headache
  • fever

Warnings



Failure to follow these warnings could result in serious consequences

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

  •  more than 4 doses in 24 hours, which is the maximum daily amoun
    • with other drugs containing acetaminophen
      • 3 or more alcoholic drinks
      • every day while using this product.

        • Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include

        • skin reddening
        • blisters
        • rash

          • If a skin reaction ccurs, 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.


Ask A Doctor Before Use If You Have



  • a sodium restricted diet
  • liver disease
  • glaucoma
  • 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 enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use



  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

When Using This Product



  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If



  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts

Pregnant Or Breast-Feeding



ask a health professional before use.


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 recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
    • AptaPharma NiteTime2 Label - AptaPharma NiteTiime2

    AptaPharma NiteTime2 Label - AptaPharma NiteTiime2


Other Information



  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Inactive Ingredients



citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose


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 sleepy

Product Label



Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR

Acetaminophen ..........................Aches, Fever and Sore Throat

Dextromethorphan ......................Cough

Doxylamine Succinate ................Sneezing, Runny nose

6 FL OZ (177 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-002

Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com

LOT:        EXP:

Peel Here  DRUG FACTS CONTINUED ON BACK

ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

  •  Antihistamine
    • Cough Suppressant
      • Pain Reliever
        • Fever Reducer


* Please review the disclaimer below.