QCH - 1149 - 2019-1004
Drug Labeling and Warnings
Drug Details [pdf]
SINUS CONGESTION AND PAIN DAYTIME NIGHTTIME- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride
Chain Drug Marketing Association
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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QCH - 1149 - 2019-1004
Uses
- for the temporary relief of:
- sinus congestion and pressure
- headache
- nasal congestion
- minor aches and pains
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
Uses
- for the temporary relief of:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- reduces swelling of nasal passages
- helps decongest sinus openings and passages
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- 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
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
In addition, when using Sinus Congestion & Pain Night:
- excitability may occur, especially in children
- 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
- 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
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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 (1-800-222-1222). 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)
- do not take Day and Night caplets at the same time
- do not take more than a total of 12 caplets in 24 hours
| adults and children 12 years and over |
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| children under 12 years |
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Other information
- store between 20º-25ºC (68º-77ºF) in a dry place
- retain carton for complete product information
Inactive ingredients
Sinus Congestion & Pain Day
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
NDC: 63868-006-20
QUALITY CHOICE
†Compare to the active ingredients in TYLENOL® Sinus Congestion & Pain Day & Night
Daytime & Nighttime, Non-Aspirin
Sinus Congestion & Pain
Pain Reliever, Nasal Decongestant, Antihistamine*
Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate*
For Relief of:
Headache
Sinus Pressure / Nasal Congestion
Runny Nose*
*Antihistamine in Nighttime Only
12 Day/8 Night Caplets
20 Cool Taste Caplets
| SINUS CONGESTION AND PAIN DAYTIME NIGHTTIME
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit |
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| Labeler - Chain Drug Marketing Association (011920774) |
Revised: 10/2019
Document Id: 94206dd0-22ee-01a6-e053-2995a90a62fe
Set id: 9043d7a3-718d-4290-ad27-a73748de2632
Version: 3
Effective Time: 20191004
Chain Drug Marketing Association