Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Daytime Sinus Capsule, Liquid Filled
FDA Label NDC 53345-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. for the product Daytime Sinus (NDC 53345-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, overdose warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Nasal decongestant
Uses
temporarily relieves sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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
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
- new symptoms occur
- symptoms do not get better within 7 days or are accompanied by a fever
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 as well as children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
adults and children 12 years of age and over | take 2 softgels with water every 4 hours |
children 4 to under 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)
Inactive Ingredients
FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
DayTime Sinus Capsules
Quantity : 4000 Capsules
NDC. No : 53345-030-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.
