Label: SEVERE CONGESTION AND COUGH- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
- Label RSS
- Share
- NDC Code(s): 0363-6048-09
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 23, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
-
Warnings
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.
Ask a doctor before use if you have
- high blood pressure
- heart disease
- difficulty in urination due to enlargement of the prostate gland
- diabetes
- thyroid disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 0363-6048-09
Walgreens
WALGREENS PHARMACIST RECOMMENDED†
Compare to active ingredients in
Maximum Strength Mucinex®
Fast-Max® Severe Congestion & Cough††Severe
Congestion
& CoughDEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
Maximum Strength
Multi-Symptom
• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus20
COATED
CAPLETSACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGDISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen Co.†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
†† This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Maximum Strength Mucinex® Fast-Max® Severe
Congestion & Cough.50844
ORG021764809PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Walgreens 44-648
-
INGREDIENTS AND APPEARANCE
SEVERE CONGESTION AND COUGH
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6048 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--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 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 NDC:0363-6048-09 2 in 1 PACKAGE 07/20/2015 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 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(0363-6048) , pack(0363-6048) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0363-6048) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(0363-6048)