| NDC | 0363-6175-01 |
| Set ID | 41f044c5-ad3c-4f31-8944-f7127fdc8240 |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)(Daytime Severe Cold)
- Purpose
- Active ingredients (in each caplet)(Nighttime Cold & Flu)
- Purpose
-
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
- temporarily relieves these common cold and flu symptoms:
-
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.
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
- Other information
- Inactive ingredients (Daytime Severe Cold)
- Inactive ingredients (Nighttime Cold & Flu)
- Questions or comments?
-
Principal Display Panel
Well at
WalgreensWALGREENS PHARMACIST RECOMMENDED‡
NDC 0363-6175-01
DAYTIME
MAXIMUM STRENGTH
Mucus Relief
Severe Cold
Acetaminophen/
Pain Reliever / Fever Reducer
Dextromethorphan HBr/
Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCl /
Nasal Decongestant• Relieves aches, fever &
sore throat
• Controls cough
• Thins & loosens mucus
• Clears nasal & chest congestion20
CAPLETS Actual SizeNIGHTTIME
MAXIMUM STRENGTHMucus Relief
Cold & Flu
Acetaminophen /
Pain Reliever / Fever Reducer,
Diphenhydramine HCl /
Antihistamine
Phenylephrine HCl /
Nasal Decongestant• Relieves aches, fever &
sore throat
• Relieves runny nose &
sneezing
•Relieves nasal
congestion10
CAPLETS Actual SizeCompare to Maximum Strength Mucinex® FAST-MAX® Daytime Severe Cold & Nighttime Cold & Flu active ingredients‡‡
30 TOTAL CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.‡Walgreens Pharmacist Survey Study, November 2014.
‡‡This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Daytime Severe Cold & Nighttime Cold & Flu.50844 REV0414B61754401 ORG0714-F_R02
Walgreens 44-617544
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DAYTIME/NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6175 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6175-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 04/07/2013 10/04/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 10 Part 2 2 BLISTER PACK 20 Part 1 of 2 MUCUS RELIEF COLD AND FLU NIGHTTIME / MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct 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) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) 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 Part 2 of 2 MUCUS RELIEF SEVERE COLD DAYTIME / MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct 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) 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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/07/2013 10/04/2021 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0363-6175) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0363-6175) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0363-6175) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0363-6175) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-6175)