Walgreens 44-455C466-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
SINUS CONGESTION AND PAIN DAYTIME/NIGHTTIME- acetaminophen, chlorpheniramine maleate, phenylephrine hcl
Walgreen Company
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Walgreens 44-455C466-Delisted
Sinus Congestion & Pain Daytime
Active ingredients (in each caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- helps decongest sinus openings and passages
- promotes sinus drainage
- temporarily reduces fever
- helps clear nasal passages
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- redness or swelling is present
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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 (1-800-222-1222) 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
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Sinus Congestion & Pain Nighttime
Active ingredients (in each caplet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Uses
- for the temporary relief of:
- sinus congestion and pressure
- runny nose and sneezing
- headache
- minor aches and pains
- nasal congestion
- helps clear nasal passages
- helps decongest sinus openings and passages
- temporarily reduces fever
- promotes sinus drainage
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- glaucoma
- heart disease
- high blood pressure
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- thyroid disease
- difficulty to in urination due to enlargement of the prostate gland
- diabetes
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- may cause drowsiness
- excitability may occur, especially in children
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
COMBO PACK
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡
|
DAYTIME NON-DROWSY
Sinus Relieves Sinus Headache & Pressure,
12 |
NIGHTTIME
Sinus Relieves Headache, Sinus Pressure,
12 |
Compare to Tylenol® Sinus Congestion & Pain Daytime & Nighttime active ingredients‡‡
24 CAPLETS
TOTAL
**Antihistamine in Nighttime Only
PSEUDOEPHEDRINE FREE
COOL BLAST FLAVOR
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
‡Walgreens Pharmacist Survey Study, November 2014.
‡‡This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark Tylenol®
Sinus Congestion & Pain Daytime & Nighttime.
50844 REV1214.455/0514.466B08
Walgreens 455C466
| SINUS CONGESTION AND PAIN
DAYTIME/NIGHTTIME
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit |
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| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(0363-4554) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(0363-4554) | |
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