FDA Label for Sinus Relief Daytime Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH LIQUID CAP)
- PURPOSE
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- ACTIVE INGREDIENT (IN EACH LIQUID CAP)
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sinus Relief Daytime Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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.
Active Ingredients (In Each Liquid Cap)
Acetaminophen 325 mg
Phenyelphrine HCl 5 mg
Purpose
Pain reliever
Nasal decongestnat
Pain reliever
Antihistamine
Nasal decongestant
Uses
- temporarily relieves nasal and sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
- temporarily relieves nasal and sinus symptoms:
- headache
- sinus pain
- nasal and sinus congestion
- runny nose and sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 liquid caps in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminohen
- 3 or more alcoholic drinks every ay while using this product
- more than 12 liquid caps in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminohen
- 3 or more alcoholic drinks every ay while using this product
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver disease
- heart disease
- high blood pressure
- glaucoma
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
- do not exceed recommended dosage
- excitability may occur, expecially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- redness or swellling is present
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swellling is present
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
These could be signs of a serious condition.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
ask a health professional before use.
Keep Out Of Reach Of Children.
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. Quickmedical 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. Quickmedical 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)
- adults and children 12 years and over
- 2 liquid caps with water every 4 hours
- do not take more than 12 liquid caps in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- take only as recommended (see overdose warning)
- adults and children 12 years and over
- 2 liquid caps with water every 4 hours
- do not take more than 12 liquid caps in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- for better identification, keep liquid caps in carton until used
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- for better identification, keep liquid caps in carton until used
Inactive Ingredients
edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol
edible white ink, FD&C blue #1, gelatin, glyercin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol
Active Ingredient (In Each Liquid Cap)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Questions Or Comments?
1-800-426-9391
Principal Display Panel
COMBO PACK
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ
NDC 0363-0555-22
NON-DROWSY • DAYTIME
Sinus Relief
Acetaminophen /
Sinus Headache & Pain
Phenylephrine HCl /
Sinus Pressure
& Congestion
32 LIQUID CAPS
NGHTTIME
Sinus Relief
Acetaminophen /
Sinus Headache & Pain
Doxylamine Succinate /
Runny Nose
Phenylephrine HCl /
Sinus Pressure & Congestion
16 LIQUID CAPS
Compare to Vicks® DayQuil® & NyQuil® Sinex® Sinus Relief LiquiCaps® active ingredientsǂǂ
48 TOTAL LIQUID CAPS
ǂWalgreens Pharmacist Survey Study, November 2010
ǂǂThis product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength Tablets.
50844 REV1012.553/554A22
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
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