SINUS AND CONGESTION RELIEF DAYTIME- acetaminophen, phenylephrine hcl capsule, liquid filled
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 44-663 - Delisted

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- sinus congestion and pressure
- fever
- nasal congestion
- headache
- minor aches and pains

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg 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

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 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
diabetes
heart disease
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

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.

Stop use and ask a doctor if

redness or swelling is present
new symptoms occur
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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
do not exceed 4 doses per 24 hours
adults and children 12 years and over: 2 capsules with water every 4 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

edible white ink, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Quality
+Plus

NDC 50844-663-02

Compare to active ingredients in Vicks® QlearQuil™ Daytime Sinus & Congestion

Sinus & Congestion Relief

DAYTIME

Acetaminophen
Phenylephrine HCl

PAIN RELIEVER / FEVER REDUCER
NASAL DECONGESTANT

Nasal and Sinus Congestion
Fever
Sinus Headache and Pain
Pseudoephedrine Free

ACTUAL SIZE

12 Liquid Caps

NON-DROWSY

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

*This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
Vicks® QlearQuil™ Daytime Sinus & Congestion.

50844 ORG061666302

Product of China
Packaged and Quality Assured in the USA

Quality Plus 44-663

SINUS AND CONGESTION RELIEF DAYTIME
acetaminophen, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-663
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	663
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50844-663-02	1 in 1 CARTON	03/01/2015	07/26/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50844-663-00	2 in 1 CARTON	03/01/2015	07/26/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50844-663-08	3 in 1 CARTON	03/01/2015	07/26/2021
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2015	07/26/2021

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(50844-663)

Revised: 7/2021

Document Id: 6a685c80-a497-4842-9649-ba882e980d1a

Set id: e902e339-b5bc-4c5d-9861-662f739ccb12

Version: 6

Effective Time: 20210714

L.N.K. International, Inc.