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  5. Label Information: Delsym Night Time Multi-symptom

FDA Label for Delsym Night Time Multi-symptom

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON

Delsym Night Time Multi-symptom Product Label

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

Other



Drug Facts

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224


Otc - Purpose



Active ingredients
(in each 15 mL)		Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine

Uses



temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • the impulse to cough to help you get to sleep

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 amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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



  • 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
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have



  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a sodium restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin.
  • taking sedatives or tranquilizers.

When Using This Product



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

Stop Use And Ask A Doctor If



  • pain or cough gets worse or lasts more than 7 days
  • 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 persistent headache. 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.


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 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



  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours.
  • Children under 12 years of age: Do not use.

Other Information



  • each 15 mL contains: sodium 19 mg
  • dosing cup provided
  • store between 20-25°C (68-77°F)
  • Keep carton for full directions for use

Inactive Ingredients



alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate


Questions?



1-888-963-3382

You may also report side effects to this phone number.


Principal Display Panel - 120 Ml Bottle Carton



NEW FORMULA – SEE NEW DOSING DIRECTIONS!

NDC 63824-186-64

Delsym®

NIGHT
TIME

MULTI-SYMPTOM

Acetaminophen
(Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Doxylamine succinate (Antihistamine)

* Please review the disclaimer below.