DRUG FACTS
Drug Labeling and Warnings
Drug Details [pdf]
NIGHT TIME SINUS- acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Chain Drug Consortium, 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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DRUG FACTS
Active ingredients (in each softgel)
Acetaminophen 325 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves nasal & sinus symptoms:
- sinus pain
- nasal & sinus congestion
- headache
- runny nose and sneezing
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hrs, 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly
Overdose warning: Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults and for children even if you do not notice any signs or symptoms
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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- glaucoma
- difficulty in urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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 exceed recommended dosage
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Directions
- take every 4 hours
- do not take more than 6 doses in 24 hours
- do not use more than directed (see Overdose warning)
- when using other night- time and day- time products, carefully read each label to ensure correct dosing
| adults and children 12 years of age and older | swallow 2 softgels with water |
| children 4 to 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain penylpropanolamine (PPA)
- *this product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Sinus
Inactive ingredients
bone gelatin, FD&C Blue No. 1, glycerin USP, polyethylene glycol 400 NF, povidone K12PF, propylene glycol USP, purified water, sorbitol special, and white edible ink.
Principal Display Panel
Multi- Symptom
Night- Time sinus Liquid capsules
Relieves:
Sinus headache
pain
congestion
Acetaminophen, Doxylamine succinate, Phenylephrine HCl
Pain reliever/ fever reducer, antihistamine, nasal decongestant
Distributed by:
Chain Drug Consortium, LLC
2300 NW Corporate blvd., suite 115
Boca Raton, FL 33431
Call toll free 1-877-753-3935
SEE NEW WARNINGS INFORMATION
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
| NIGHT TIME SINUS
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled |
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| Labeler - Chain Drug Consortium, LLC (101668460) |