DAYTIME MUCUS RELIEF SEVERE COLD/NIGHTTIME MUCUS RELIEF COLD AND FLU- acetaminophen, dextromehtorphan hbr, guaifenesin, phenylephrine hcl/acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

Daytime Mucus Relief Severe Cold/Nighttime Mucus Relief Cold and Flu by

Drug Labeling and Warnings

Daytime Mucus Relief Severe Cold/Nighttime Mucus Relief Cold and Flu 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) (Daytime Severe Cold)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet) (Nighttime Cold & Flu)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • headache
  • minor aches and pains
  • nasal congestion
  • sore throat
  • cough (Daytime Severe Cold only)
  • runny nose and sneezing (Nighttime Cold & Flu only)
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime Severe Cold only)
• temporarily reduces fever

Warnings

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

• with other drugs containing acetaminophen
• more than 12 caplets in 24 hours, which is the maximum daily amount
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin (Nighttime Cold & Flu only)

Ask a doctor before use if you have

• heart disease
• liver disease
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• high blood pressure
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime Severe Cold only)
• cough that occurs with too much phlegm (mucus) (Daytime Severe Cold only)
• a breathing problem such as emphysema or chronic bronchitis (Nighttime Cold & Flu only)
• glaucoma (Nighttime Cold & Flu only)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Nighttime Cold & Flu only)

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children (Nighttime Cold & Flu only)
• marked drowsiness may occur (Nighttime Cold & Flu only)
• avoid alcoholic drinks (Nighttime Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime Cold & Flu only)
• be careful when driving a motor vehicle or operating machinery (Nighttime Cold & Flu only)

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache (Daytime Severe Cold only)

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.

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

• do not use more than directed (see overdose warning)
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 12 caplets in 24 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)
• use by expiration date on package

Inactive ingredients (Daytime Severe Cold)

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, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime Cold & Flu)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™

NDC: 49035-997-01

Compare to
Mucinex®
FAST-MAX®
DAY TIME Severe
Cold and NIGHT TIME
Cold & Flu
Active
ingredients*

• Daytime Mucus ReliefSevere Cold Acetaminophen - Pain Reliever/Fever Reducer, Dextromethorphan HBr -Cough Suppressant, Guaifenesin - Expectorant, Phenylephrine HCl -Nasal Decongestant Relieves pain, fever, sorethroat and head & chestcongestion Thins & loosens mucus Controls cough 20DAYTIMECAPLETS Actual Size:

  Nighttime

  Mucus Relief; Cold & Flu

  Acetaminophen -; Pain Reliever/Fever Reducer,

  Diphenhydramine HCl -; Antihistamine,

  Phenylephrine HCl - ; Nasal Decongestant

  Relieves pain, fever, sore; throat and nasal congestion

  Relieves runny nose & ; sneezing

  Ages 12+

  Pseudoephedrine Free

  10; NIGHTTIME; CAPLETS Actual Size

Satisfaction guaranteed - for questions
or comments please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by Reckitt
Benckiser LLC, owner of the registered trademark Maximum
Strength Mucinex® FAST-MAX® DAY TIME Severe Cold &
NIGHT TIME Cold & Flu.

50844                   REV0414A61754401

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

Equate 44-617544

INGREDIENTS AND APPEARANCE

DAYTIME MUCUS RELIEF SEVERE COLD/NIGHTTIME MUCUS RELIEF COLD AND FLU 
acetaminophen, dextromehtorphan hbr, guaifenesin, phenylephrine hcl/acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-997

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-997-01	1 in 1 CARTON; Type 0: Not a Combination Product	04/07/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	20
Part 2	1 BLISTER PACK	10

Part 1 of 2

MUCUS RELIEF SEVERE COLD  DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;617
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	04/07/2013

Part 2 of 2

MUCUS RELIEF COLD AND FLU  NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;544
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	09/19/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/07/2013

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-997)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-997)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(49035-997)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(49035-997)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(49035-997)