Daytime Sinus Relief and Nighttime Sinus Relief
Daytime Sinus Relief and Nighttime Sinus Relief by
Drug Labeling and Warnings
Daytime Sinus Relief and Nighttime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hydrochloride
PuraCap Pharmaceutical 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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Daytime Sinus Relief and Nighttime Sinus Relief
Active ingredients for Nighttime Sinus (in each softgel)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Active ingredients for Daytime Sinus (in each softgel)
Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg
Uses
- temporarily relieves symptoms due to the common cold
- minor aches and pains
- headache
- fever
- runny nose and sneezing (Nighttime only)
- nasal congestion
- sinus congestion & pressure
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies
- minor aches and pains
- headache
- runny nose and sneezing (Nighttime only)
- itching of the nose or throat, and itchy, watery eyes (Nighttime only)
- nasal congestion
- sinus congestion & pressure
Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 10 softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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 sleep (Nighttime only)
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- glaucoma (Nighttime only)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers (Nighttime only)
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed, in addition when using Nighttime Sinus and Congestion:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives & tranquilizers may increase drowsiness
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
|
Age |
Daytime Sinus |
Nighttime Sinus |
|
adults and children 12 yrs & over |
2 softgels with water every 4 hrs |
2 softgels with water every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
ask a doctor |
|
children under 4 yrs |
do not use |
do not use |
Inactive ingredients
Nighttime Sinus: FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink
Daytime Sinus: FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink
Principal Display Panel
CVS Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS
NDC: 51013-114-13
Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*
| DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF
acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit |
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| Labeler - PuraCap Pharmaceutical LLC (962106329) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 421293287 | manufacture(51013-114) , analysis(51013-114) | |