Delsym Night Time Cough and Cold
Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-185
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
COUGH & COLD
|Active ingredients (in each 5 mL)||Purpose|
|Diphenhydramine HCl, USP 6.25 mg||Antihistamine/
|Phenylephrine HCl, USP 2.5 mg||Nasal decongestant|
- temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
- temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itchy nose or throat
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on the skin
- 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
- heart disease
- high blood pressure
- thyroid 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)
Ask a doctor or pharmacist before use if 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
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away.
- do not take more than directed
- do not take more than 6 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
|Age (year)||Dose (mL)|
|Adults and children|
12 years of age and older
|20 mL every 4 hours|
|Children 6 to under 12 years of age||10 mL every 4 hours|
|Children 4 to under 6 years of age||do not use unless
directed by a doctor
|Children under 4 years of age||do not use|
- each 5 mL contains: sodium 3 mg
- tamper evident: do not use if printed neckband on bottle cap is broken or missing
- dosing cup provided
- store between 20-25°C (68-77°F)
- Keep carton for full directions for use
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
NEW FORMULA – READ ENTIRE LABEL!
COUGH & COLD
120 mL (4 fl oz)
|DELSYM NIGHT TIME
COUGH AND COLD
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
|Labeler - Reckitt Benckiser LLC (094405024)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.