Daytime Sinus Relief And Nighttime Sinus Relief
FDA Label NDC 63868-464

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Daytime Sinus Relief And Nighttime Sinus Relief (NDC 63868-464). 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 for nighttime sinus (in each softgel), active ingredients for daytime sinus (in each softgel), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients For Nighttime Sinus (in Each Softgel)

→ Active Ingredients For Daytime Sinus (in Each Softgel)

→ Purposes

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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

Purposes

Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant

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

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

Stop Use And Ask A Doctor If

pain or nasal congestion gets worse or last more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
you get nervous, dizzy or sleepless

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

take only as directed
do not exceed 4 doses per 24 hours

Age	Daytime Sinus	Nighttime Sinus
adults and children 12 years and over	2 softgels with water every 4 hours	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor	ask a doctor
children under 4 years	do not use	do not use