Quality Plus 44-466C-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hcl tablet, film coated
L.N.K. International, Inc.
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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Quality Plus 44-466C-Delisted
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hour, which is the maximum daily amount
- 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:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
-
difficulty in urination due to enlargement of the prostate gland
-
heart disease
-
diabetes
-
thyroid disease
-
high blood pressure
Directions
-
do not take more than directed
-
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
-
see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
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
Principal Display Panel
QUALITY PLUS
NDC: 50844-466-02
*Compare to the active ingredients in Tylenol® SINUS + HEADACHE
DAYTIME
NON-DROWSY
SINUS
CONGESTION & PAIN
Acetaminophen, Phenylephrine HCl
Pain reliever/Fever reducer, Nasal decongestant
For Relief of:
Sinus Headache Sinus Pressure Nasal Congestion
12 Caplets
Pseudoephedrine Free
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE.
50844 REV0316E46602
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
Quality Plus 44-466C
| SINUS CONGESTION AND PAIN
DAYTIME
acetaminophen and phenylephrine hcl tablet, film coated |
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| Labeler - L.N.K. International, Inc. (038154464) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(50844-466) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(50844-466) | |