DayTime Nitetime Sinus Relief by TOP CARE (Topco Associates LLC) Drug Facts
DayTime Nitetime Sinus Relief by
Drug Labeling and Warnings
DayTime Nitetime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
DAYTIME NITETIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hcl
TOP CARE (Topco Associates 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 Nighttime (in each softgel)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves nasal and sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
- runny nose and sneezing (Nighttime only)
Warnings
Liver warning: These products contain 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
Do not use
- to make a child sleep (Nighttime only)
- 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
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product,
do not exceed recommended dosage. In addition, when using Nighttime:
- 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
Stop use and ask a doctor if
- 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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can 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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.
Nighttime: adults and children 12 years and over: take 2 softgels with water every 4 hours.
- children under 12 years: do not use
Inactive ingredients in Daytime
edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Inactive ingredients in Nighttime
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Principal Display Panel
When using Daytime and Nighttime products, carefully read the labeling to insure correct dosing
NON-DROWSY Daytime Sinus Relief
PAIN RELIEVER AND NASAL DECONGESTANT
- Aches: ACETAMINOPHEN, 325 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
†Supports Children's Miracle Network Hospitals Helping Local Kids
DAYTIME SOFTGELS
MULTI-SYMPTOM Nitetime Sinus Relief
PAIN RELIEVER, ANTIHISTAMINE, AND NASAL DECONGESTANT
- Aches: ACETAMINOPHEN, 325 mg
- Sneezing/Runny Nose: Doxylamine succinate, 6.25 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
COMPARE TO VICKS® DAYQUIL® AND NYQUIL® SINEX® LIQUICAPS® active ingredients*
NITETIME SOFTGELS
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® Sinex® LiquiCaps®.
†A portion of the proceeds from this purchase will support the Children's Miracle Network Hospitals.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
1-888-423-0139 topcare@topco.com
Product of Canada
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
| DAYTIME NITETIME SINUS RELIEF
acetaminophen, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - TOP CARE (Topco Associates LLC) (006935977) |