Delsym Night Time Cough and Cold
- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 120 mL Carton
FULL PRESCRIBING INFORMATION
|Active ingredients (in each 15 mL)||Purpose|
|Acetaminophen 500 mg||Pain reliever/Fever reducer|
|Dextromethorphan HBr 15 mg||Cough suppressant|
|Doxylamine Succinate 6.25 mg||Antihistamine|
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
- the impulse to cough to help you get to sleep
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.
Ask a doctor before use if you have
- liver disease
- 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.
- you are 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.
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children.
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.
- 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.
- each 15 mL contains: sodium 23 mg
- tamper evident: do not use if seal under bottle cap printed "SEALED for YOUR PROTECTION" is torn or missing
- dosing cup provided
- store between 15-30°C (59-86°F)
- Keep carton for full directions for use
anhydrous citric acid, anhydrous trisodium citrate, FD&C Blue #1, FD&C Red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sugar
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
PRINCIPAL DISPLAY PANEL - 120 mL Carton
SEE NEW WARNINGS
COUGH & COLD
(Pain Reliever / Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Doxylamine succinate (Antihistamine)
- Runny Nose & Sneezing
- Sore Throat
- Body Aches
120 mL (4 fl oz)
for Ages 12+
Delsym Night Time Cough and Cold
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate SOLUTION