FDA Label for Daytime And Nighttime Sinus Relief
View Indications, Usage & Precautions
- DAYTIME SINUS RELIEF
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- OTHER
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- NIGHTTIME SINUS RELIEF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- NIGHTTIME SEVERE COLD & FLU SOFTGELS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Daytime And Nighttime Sinus Relief 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.
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.