FDA Label for Severe Sinus Congestion And Cough Daytime Non-drowsy / Nightime

View Indications, Usage & Precautions

Severe Sinus Congestion And Cough Daytime Non-drowsy / Nightime Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

SEVERE SINUS CONGESTION & COUGH DAYTIME SOFTGELS

Drug Facts

SEVERE SINUS CONGESTION & COUGH NIGHTTIME SOFTGELS

Drug Facts

Otc - Purpose

Active Ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Active Ingredients (in each softgel)	Purpose
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 these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- nasal congestion
- sore throat
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages and shrinks swollen membranes
- temporarily reduces fever

Liver Warning

This product contains 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

This product contains 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

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.

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.

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.
If you have ever had an allergic reaction to this product or any of its ingredients
In children under 12 years of age

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
cough with excessive phlegm(mucus)
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough with excessive phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

pain, cough or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs.

pain, cough, 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
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

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. 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.

Overdose Warning

Taking more than the recommended dose (overdose) may 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

take only as recommended (see overdose warning)
do not take more than recommended dose
adults and children 12 years and over :take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor
children under 12 years: do not use

do not take more than the recommended dose
adults and children 12 years and over: take 2 softgels with water every 4 hours.

Do not exceed 10 softgels in 24 hours or as directed by a doctor.

children under 12 years: do not use

Other Information

store at room temperature. Avoid excessive heat.

store at room temperature. Avoid excessive heat.

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Otc - Do Not Use

Do not use to sedate children.

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.
in children under 12 years of age
If you have ever had an allergic reaction to this product or any of its ingredients

When Using This Product

do not exceed recommended dosage
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Principal Display Panel - Kit Carton

DAY & NIGHT PACK

NDC 0363-9890-20

Walgreens

Compare to Alka-Seltzer PLUS® Day and Night Severe Sinus Congestion & Cough active ingredients‡‡

DAYTIMENON-DROWSY

Severe Sinus
Congestion & Cough

ACETAMINOPHEN/

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr/COUGH SUPPRESSANT

PHENYLEPHRINE HCL/NASAL CONGESTANT

Pain reliever, fever reducer,

cough suppressant &
nasal decongestant

Actual Size

12 SOFTGELS

NIGHTTIME