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

Severe Congestion Relief by

Drug Labeling and Warnings

Severe Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, 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 7days
• 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 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 older: take 2 caplets every 4 hours
• children under 12 years of age: do not use

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 15º-30ºC (59º-86ºF)

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?

1-888-287-1915

Principal display panel

equate™                                                                                                                                                               NDC: 49035-165-09

Maximum Strength Sinus                                             Compare to Maximum Strength Mucinex®SINUS-MAX®
                                                                                      Severe Congestion Relief Active Ingredients*

Severe Congestion Relief

Acetaminophen - Pain Reliever,
Guaifenesin - Expectorant,
Phenylephrine HCl - Nasal Decongestant

• Relieves headache
• Thins & loosens mucus
• Relieves sinus congestion

For Ages 12+                                    20 CAPLETS                                Actual Size

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

Satisfaction guaranteed - For questions or comments please call 1-800-287-1915

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief.

50844      REV1117A61509                                                                                                                       729665

44-615

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-165
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE (UNII: 2S7830E561)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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: 49035-165-09	2 in 1 CARTON	06/30/2014
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	06/30/2014

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-165)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-165)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(49035-165)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(49035-165)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(49035-165)