SINUS RELIEF NON-DROWSY DAYTIME- acetaminophen, phenylephrine hcl capsule, liquid filled

Sinus Relief by

Drug Labeling and Warnings

Sinus Relief by is a Otc medication manufactured, distributed, or labeled by Better Living Brands, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

• temporarily relieves nasal and sinus symptoms:
  • fever
  • sinus pain
  • headache
  • nasal and sinus congestion

Warnings

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

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• 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
• diabetes
• heart disease
• thyroid disease
• high blood pressure
• difficulty in urination due to an 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.

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

• take only as directed (see overdose warning)
• 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

If taking NIGHTTIME and DAYTIME products, carefully read each label to ensure correct dosing.

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• 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

NDC: 21130-663-08

Signature™
care

Quality Guaranteed

Non-Drowsy
Daytime
Sinus Relief

Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Phenylephrine HCl 5 mg - Nasal Decongestant

COMPARE TO
Vicks® DayQuil®
Sinex® Daytime
Sinus Relief
LiquiCaps®
active ingredients*

Sinus headache & pain
Sinus pressure & congestion
Pseudoephedrine free

Actual Size

24 LIQUID CAPS

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 Procter & Gamble,
distributors of Vicks® DayQuil® Sinex® Daytime Sinus Relief LiquiCaps®.
50844                ORG081466308

Product of China
Packaged and Quality Assured in the USA

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com

OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK

Signature Care 44-663

INGREDIENTS AND APPEARANCE

SINUS RELIEF  NON-DROWSY DAYTIME
acetaminophen, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-663
Route of Administration	ORAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-663-08	2 in 1 CARTON	03/01/2015
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2015

Labeler - Better Living Brands, LLC (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(21130-663)