DELSYM COUGH PLUS COLD DAY TIME AND DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride
Reckitt Benckiser LLC
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.
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Delsym® Cough Plus™ Cold Day Time and Delsym® Cough Plus™ Cold Night Time
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (Night Time only)
- controls cough to help you get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Day Time only)
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs that contain 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.
- with any other drug containing diphenhydramine, even one used on the skin (Night Time only)
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (Night Time only)
- a breathing problem such as emphysema or chronic bronchitis (Night Time only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Night Time only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Night Time only)
- marked drowsiness may occur (Night Time only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
- avoid alcoholic drinks (Night Time only)
- be careful when driving a motor vehicle or operating machinery (Night Time only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided with product
- dose as follows or as directed by a doctor
- mL = milliliter
- adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Other information
- each 20 mL contains: sodium 12 mg
- do not refrigerate
- store between 20-25°C (68-77°F)
- dosing cup provided
Inactive ingredients (Delsym Cough+ Cold Day Time)
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum
- 1
- may contain this ingredient
Inactive ingredients (Delsym Cough+ Cold Night Time)
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 63824-217-22
COMBO
PACK
Delsym®
COUGH+™COLD
DAY TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)
✓ Cough ✓ Sore Throat ✓ Headache
✓ Nasal & Chest Congestion ✓ Fever
NIGHT TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
✓ Cough ✓ Sore Throat ✓ Fever
✓ Nasal Congestion ✓ Body Aches
TWO – 6 fl oz (180 mL) bottles
TOTAL – 12 fl oz (360 mL)
For Ages 12+
Mixed Berry
Flavored Liquid
| DELSYM COUGH PLUS COLD DAY TIME AND DELSYM COUGH PLUS COLD NIGHT TIME
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit |
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| Labeler - Reckitt Benckiser LLC (094405024) |