SEVERE SINUS CONGESTION AND PAIN MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated

Severe Sinus Congestion and Pain by

Drug Labeling and Warnings

Severe Sinus Congestion and Pain 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 caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant

Uses

• temporarily relieves:
  • nasal congestion
  • headache
    
  • sinus congestion and pressure
  • minor aches and pains
    
• temporarily promotes nasal and/or sinus drainage
  
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

• with other drugs containing acetaminophen
• more than 4,000 mg of acetaminophen in 24 hours
• 3 or more alcoholic drinks every day while using this product

 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash 

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
• thyroid disease
• diabetes
  
• heart disease
• high blood pressure
  
• difficulty in urination due to enlargement of the prostate gland
  
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  
• cough that occurs with too much phlegm (mucus)
  

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

• nervousness, dizziness, or sleeplessness occur
  
• fever gets worse or lasts more than 3 days
  
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
  
• redness or swelling is present
  
• new symptoms occur
  
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  

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

• do not take more than directed
  
• do not take more than 12 caplets in any 24-hour period
  
• adults and children 12 years and over: take 2 caplets every 4 hours
  
• children under 12 years: do not use
  

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

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Compare to the active ingredients in Maximum Strength 
Mucinex® SINUS-MAX® Severe Congestion & Pain*

NDC: 21130-615-09

Signature 
Care™

Quality Guaranteed

Maximum Strength

Severe Sinus
Congestion & Pain

Acetaminophen       Pain Reliever
Guaifenesin               Expectorant
Phenylephrine HCl    Nasal Decongestant

Relieves Headache
Thins and Loosens Mucus
Relieves Sinus Congestion

ACTUAL SIZE

20 FILM COATED ORANGE CAPLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributors of
Maximum Strength Mucinex® SINUS-MAX® Severe Congestion & Pain.

50844 ORG111761509

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

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

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

Signature care 44-615

INGREDIENTS AND APPEARANCE

SEVERE SINUS CONGESTION AND PAIN  MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-615
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;615
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-615-09	2 in 1 CARTON	06/30/2013
1		10 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	06/30/2013

Labeler - Better Living Brands, LLC (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(21130-615)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(21130-615)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(21130-615)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(21130-615)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(21130-615)