SEVERE CONGESTION AND COUGH, COLD AND FLU DAYTIME AND NIGHTTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit

severe congestion and cough, cold and flu by

Drug Labeling and Warnings

severe congestion and cough, cold and flu by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet) (Daytime Severe Congestion & Cough)

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

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

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Uses (Daytime only)

• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • nasal congestion due to a cold
  • the intensity of coughing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Uses (Nighttime only)

• temporarily relieves these common cold and flu symptoms:
  • headache
  • sore throat
  • nasal congestion
  • runny nose and sneezing
  • cough
  • minor aches and pains
• temporarily reduces fever
• controls cough to help you get to sleep

Warnings (Nighttime only)

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:

• blisters
• rash
• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

• 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
• if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
• with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are (Nighttime only)

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever (Daytime only)
• redness or swelling is present (Nighttime only)
• pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
• new symptoms occur (Nighttime only)
• fever gets worse or lasts more than 3 days (Nighttime only)
• 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.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions

• do not use 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 (Daytime only)

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Rite 
Aid®
PHARMACY

*Compare to the active ingredients
in Maximum Strength Mucinex®
FAST-MAX® Day Time Severe
Congestion & Cough and
Night Time Cold & Flu

MAXIMUM STRENGTH

• daytime severecongestion& cough dextromethorphan HBrguaifenesin phenylephrine HCl cough suppressantexpectorantnasal decongestant controls cough relieves nasal &chest congestion thins & loosens mucus ACTUALSIZE 20 DAYTIMECAPLETS:

  nighttime; cold &; flu

  acetaminophen ; diphenhydramine HCl; phenylephrine HCl

  pain reliever/fever reducer; antihistamine/ cough suppressant; nasal decongestant

  relieves aches, fever; & sore throat

  controls cough

  relieves nasal congestion

  relieves runny nose & sneezing

  ACTUAL; SIZE

  10 NIGHTTIME; CAPLETS

for ages 12+

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 Reckitt
Benckiser LLC, owner of the registered trademark Maximum
Strength Mucinex® FAST-MAX® Day Time Severe Congestion
& Cough and Night Time Cold & Flu.
50844                ORG051764869401

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED,
WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-648694

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION AND COUGH, COLD AND FLU  DAYTIME AND NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6489

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6489-1	1 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2017

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

SEVERE CONGESTION AND COUGH  DAYTIME
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED (maroon)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;648
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	07/20/2015

Part 2 of 2

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	12.5 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)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;694
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	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2017

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-6489)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(11822-6489)