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  5. Label Information: Xl-3 Night Time

FDA Label for Xl-3 Night Time

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSAGE
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Xl-3 Night Time Product Label

The following document was submitted to the FDA by the labeler of this product Rnv 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.

Otc - Active Ingredient



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 12.5 mg


Otc - Purpose



Pain reliever/fever reducer

Cough Suppressant

Antihistamine


Indications & Usage



Uses

temporarily relieves cold/flu symptoms:

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

Warnings



Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

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

      Sore throat warning: If sore throat is sever, lasts 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 products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
      • for more than 10 days for pain unless directed by a doctor
      • for more than 3 days for fever unless directed by a doctor
      • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), or for 2 weeks after stopping the MAOI drugs. 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

Otc - Ask Doctor/Pharmacist



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 wtih 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.

Otc - When Using



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.

Otc - Stop Use



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
  • rever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs wih fever, rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if ou do not notice any signs or symptoms.


Dosage & Administration



  • take only as recommended- see Overdose warning
  • use only dosing cup provided
  • keep dosing cup provided with the product
  • do not exceed 4 doses per 24 hours
  • if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours
  • TBSP=tablespoon
  • mL=mililiter
    •  adults & children 12 years and over 30 mL (2 TBSP) every 6 hours
     children 4 to under 12 yearsask a doctor 
     children under 4 yearsdo not use 


Other Safety Information



Other information

  • each 30 mL contains: sodium 10 mg
  • store between 58 - 86 degrees F (15-30 degrees C)

Inactive Ingredient



Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Otc - Questions



Questions or Comments? 1-888-446-4753

Monday - Friday from 8 AM - 5 PM Eastern Standard Time


Package Label.Principal Display Panel



XL3 Night - XL 3Night

XL3 Night - XL 3Night


* Please review the disclaimer below.