MedPath

Mucus Relief Cold, Flu and Sore Throat

TopCare 44-005

Approved
Approval ID

6207ef50-4f28-4dbc-9a52-f44dd53d2a4f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 11, 2025

Manufacturers
FDA

TOPCO ASSOCIATES LLC

DUNS: 006935977

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76162-050
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2025
FDA Product Classification

INGREDIENTS (16)

ACETAMINOPHENActive
Quantity: 650 mg in 20 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 20 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 20 mL
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 20 mL
Code: 04JA59TNSJ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

Principal Display Panel

+TopCare®
**** health

NDC 76162-050-45
COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX®
COLD, FLU & SORE THROAT ACTIVE INGREDIENTS*

MAXIMUM STRENGTH
Mucus Relief
Cold, Flu & Sore Throat

ACETAMINOPHEN
PAIN RELIEVER • FEVER REDUCER
DEXTROMETHORPHAN HBr • COUGH SUPPRESSANT
GUAIFENESIN • EXPECTORANT
PHENYLEPHRINE HCl • NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:
• Relieves Body Pain & Headache
• Controls Cough
• Relieves Nasal &
Chest Congestion
• Thins & Loosens
Mucus

FOR AGES 12+
6 FL OZ (177 mL)
Mixed Berry
Flavored

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0223 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/4902b5

QUALITY GUARANTEED

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

*This product is not manufactured or distributed by RB Health (US) LLC, owner
of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold,
Flu & Sore Throat. 50844 ORG052300545

TopCare 44-005

TopCare 44-005

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/11/2025

Uses

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • sinus congestion and pressure
    • stuffy nose
    • cough
    • headache
    • nasal congestion
    • sore throat
  • temporarily promotes nasal and/or sinus drainage
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/11/2025

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/11/2025

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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

  • 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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

Directions

*do not take more than directed

  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • dose as follows or as directed by a doctor
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/11/2025

Other information

*each 20 mL contains: sodium 10 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/11/2025

Questions or comments?

1-888-423-0139

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