Daytime And Nighttime Sinus Relief
FDA Label NDC 0363-9014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Daytime And Nighttime Sinus Relief (NDC 0363-9014). 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 daytime sinus relief, otc - active ingredient, otc - purpose, uses, warnings, other, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Daytime Sinus Relief

Otc - Active Ingredient

Drug Facts

Drug Facts

Otc - Purpose

Active ingredients (in each softgel)                                Purposes
Acetaminophen 325 mg............................Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.............................Cough suppressant
Guaifenesin 200 mg.........................................................Expectorant
Phenylephrine HCl 5 mg......................................Nasal decongestant

Active ingredients (in each softgel)                              Purposes
Acetaminophen 325 mg............................Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.............................Cough suppressant
Doxylamine succinate 6.25 mg.....................................Antihistamine
Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

■ temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure
■ cough due to minor throat & bronchial irritation
■ minor aches & pains ■ headache
■ fever ■ sore throat ■ reduces swelling of nasal passages
■ temporarily restores freer breathing through the nose
■ promotes nasal and/or sinus drainage
■ helps loosen phlegm (mucus) and thin bronchial secretions to
rid the bronchial passageways of bothersome mucus and make
coughs more productive.

■ temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure
■ cough due to minor throat & bronchial irritation
■ cough to help you sleep ■ minor aches & pains ■ headache
■ fever ■ sore throat ■ runny nose & sneezing
■ reduces swelling of nasal passages
■ temporarily restores freer breathing through the nose
■ promotes nasal and/or sinus drainage

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 every day while using this product

Allergy alert Acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever, headache, rash,
nausea, or vomiting, consult a doctor promptly.

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 every day while using this product

Allergy alert Acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning If sore throat is severe, persists for more than 2
days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.

Other

Drug Facts (continued)

Drug Facts (continued)

NIGHTTIME Sinus Relief

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.

■ 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

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes
■ trouble urinating due to enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking,
asthma, chronic bronchitis, or emphysema

■ liver disease ■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes ■ glaucoma
■ cough that occurs with too much phlegm (mucus)
■ a breathing problem or chronic cough that lasts or as occurs with
smoking, asthma, chronic bronchitis, or emphysema
■ trouble urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood
thinning drug warfarin.

Otc - When Using

When using this product, do not use more than directed.

Stop Use And Ask A Doctor If

■ you get nervous, dizzy or sleepless
■ pain, nasal congestion, or cough 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
■ cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.

■ you get nervous, dizzy or sleepless
■ pain, nasal congestion, or cough 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
■ cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

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. Quick medical attention is critical
for adults as well as for children even if you do not notice any signs
or symptoms.

Taking more than directed can cause serious
health problems. 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

■ take only as directed - see Overdose warning
■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over 2 softgels with water every
4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

■ when using other Nighttime or Daytime products, carefully read
each label to ensure correct dosing

■ take only as directed - see Overdose warning
■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over 2 softgels with water every
4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

Other Information

■ store at room temperature

store at room temperature

Inactive Ingredients

FD&C Yellow # 6, gelatin,
glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan , titanium
dioxide

D&C Yellow# 10, FD&C
Blue# 1, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol
sorbitan, sodium hydroxide*, titanium dioxide
* may contain this ingredient

Nighttime Sinus Relief

Drug Facts (continued)

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin

When Using This Product

■ do not use more than directed
■ 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

Nighttime Severe Cold & Flu Softgels

Drug Facts (continued)

Questions Or Comments?

Call toll free: 1-888-333-9792

Principal Display Panel



DAYTIME SINUS RELIEF

ACETAMINOPHEN /

PAIN RELIEVER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

16SOFTGELS

NIGHTTIME SINUS RELIEF

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

8SOFTGELS

TOTAL 24 SOFTGELS

* Please review the disclaimer below.