Nitetime Sinus Relief by TOP CARE (Topco Associates LLC)
Medically reviewed on December 6, 2017
Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-101
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.
Acetaminophen 325 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
- temporarily relieves nasal and sinus symptoms:
- sinus pain
- nasal and sinus congestion
- runny nose and sneezing
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- to make a child sleep
- 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.
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- do not exceed recommended dosage
- 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, and tranquilizers may increase drowsiness
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose could 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 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nitetime products, carefully read each label to insure correct dosing
- store at room temperature 15°-30°C (59°-86°F)
- avoid excessive heat
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Call toll free 1-888-423-0139
Nitetime Sinus Relief
PAIN RELIEVER, ANTIHISTAMINE AND NASAL DECONGESTANT
- Aches: ACETAMINOPHEN
- Sneezing/Runny Nose: Doxylamine succinate
- Nasal Congestion: Phenylephrine HCl
COMPARE TO VICKS® NYQUIL® SINEX® LIQUICAPS® active ingredients*
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® Sinex® LiquiCaps®.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Product of Canada
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
|NITETIME SINUS RELIEF
acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
|Labeler - TOP CARE (Topco Associates LLC) (006935977)|
|Registrant - P and L Development of New York Corporation (800014821)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.