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  5. Label Information: Xl-3 Day Time

FDA Label for Xl-3 Day 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 Day 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

Phenylephrine HCl 5 mg


Otc - Purpose



Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant


Indications & Usage



Uses

temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings



Warnings

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

  • adult takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adults has 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
    • ras

      • 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.

Otc - Ask Doctor/Pharmacist



Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabete
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

    • Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.


Otc - When Using



When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks

Otc - Stop Use



Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with 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 directed- 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 4 hours
     children 6 to under 12 years   15 mL (1 TBSPO) every 4 hours 
     children 4 to under 6 yearsask a doctor 
     children under 4 yearsdo not use 


Other Safety Information



Other information

  • each 15 mL contains: sodium 5 mg
  • store between 58 - 86 degrees F (15-30 degrees C)

Inactive Ingredient



Inactive ingredients: Citric acid, FD&C Yellow No 6, 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 Day - XL3Day

XL3 Day - XL3Day


* Please review the disclaimer below.