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

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Meijer 44-648694 Clamshell Delisted

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)

Uses (Nighttime only)

Warnings (Nighttime only)

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

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

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 tranquilizer

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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

Other information

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

COMBO PACK
Total 30 Caplets

NDC 41250-848-01

Meijer®

Compare to Maximum
Strength Mucinex®
FAST-MAX® DAY TIME
Severe Congestion
& Cough
active ingredients*

Daytime
severe
cough &
congestion

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Cough Suppressant
Expectorant
Nasal Decongestant

MAXIMUM STRENGTH

• Controls Cough,
• Relieves Nasal & Chest Congestion
• Thins & Loosens Mucus

20 Caplets

Actual Size 

Meijer®

Compare to Maximum
Strength Mucinex®
FAST-MAX® NIGHT TIME
Cold & Flu
active ingredients*

Nighttime

cold &
flu

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant

MAXIMUM STRENGTH

• Relieves Aches, Fever & Sore Throat
• Relieves Nasal Congestion, Runny nose
& Sneezing • Controls Cough

10 Caplets

Actual Size 

*This product is not manufactured or distributed by RB Health
(US) LLC, owner of the registered trademark Maximum
Strength Mucinex® FAST-MAX® Day Time Severe Congestion
& Cough and Night Time Cold & Flu.
50844 REV1021B64869401

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

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

Meijer 44-648694

Meijer 44-648694

SEVERE COUGH AND CONGESTION AND COLD AND FLU  DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-848
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-848-011 in 1 CARTON; Type 0: Not a Combination Product07/01/201701/29/2026
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 21 BLISTER PACK 10 
Part 1 of 2
SEVERE COUGH AND CONGESTION  DAYTIME
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (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
Colorred (Maroon) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;648
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/20/2015
Part 2 of 2
COLD AND FLU  NIGHTTIME
acetaminophen. diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;694
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/201701/29/2026
Labeler - Meijer Distribution Inc (006959555)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(41250-848) , pack(41250-848)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(41250-848)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(41250-848)

Revised: 3/2024
Document Id: 055188cd-ee38-4cba-b8d3-b28033d787de
Set id: 9080aec3-4927-4932-a231-7776b12bf61e
Version: 9
Effective Time: 20240304
 
Meijer Distribution Inc