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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Active ingredients for Sinus NITETIME (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
- runny nose and sneezing (Nitetime Sinus only)
- nasal and sinus congestion
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount
- with any other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using these products
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
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nitetime Sinus only)
- glaucoma (Nitetime Sinus only)
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 use more than directed, in addition when using Nitetime Sinus:
- 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
- redness or swelling is present
- you get nervous, dizzy, or sleepless
- fever gets worse or lasts more than 3 days
- symptoms do not get better within 7 days or are accompanied by a fever
- new symptoms occur
These may be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose could 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 as well as children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see Overdose warning)
- do not exceed 4 doses in 24 hours
- when using other Nitetime and Daytime products, carefully read each label to ensure correct dosing
| age | Nitetime Sinus | Daytime Sinus | |
| adults and children 12 years of age and over | take 2 softgels with water every 4 hours | take 2 softgels with water every 4 hours | |
| children 4 to under 12 years of age | ask a doctor | ask a doctor | |
|
children under 4 years of age | do not use | do not use | |
- if taking Nitetime and Daytime softgels limit total to 4 doses per day
Inactive ingredients
Nitetime 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
NON-DROWSY Daytime Sinus Relief
- Aches: ACETAMINOPHEN, 325 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
PAIN RELIEVER AND NASAL DECONGESTANT
MULTI-SYMPTOM Nitetime Sinus Relief
- Aches: ACETAMINOPHEN, 325 mg
- Sneezing/Runny Nose: Doxylamine succinate, 6.25 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
PAIN RELIEVER, ANTIHISTAMINE, AND NASAL DECONGESTANT
Compare to VICKS® DAYQUIL® NYQUILl® SINEX® active ingredients*
†Supports Children's Miracle Network Hospitals Helping Local Kids
DAYTIME SOFTGELS NITETIME SOFTGELS
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Sinex® and Vicks® NyQuil® Sinex®.
†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 ©TOPCO PLV712
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
| DAYTIME NITETIME SINUS RELIEF
acetaminophen, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - TOP CARE (Topco Associates LLC) (006935977) |
| Registrant - P and L Development of New York Corporation (800014821) |