Severe Cold and Mucus

Manufacturer
Family Dollar, Inc. | Aurohealth LLC
Effective date
2020-11-19
Label type
Human OTC Drug Label
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:05:15

Label at a glance#

ProductSevere Cold and Mucus
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over take 30 mL in the dosing cup provided every 4 hours while symptoms last do not take more than 150 mL in 24 hours, unless directed by a doctor children under 12 years ask a doctor

Storage and handling

each 15 mL contains: sodium 5 mg store at 20-25˚C (68-77˚F). Do not refrigerate. do not use if printed shrinkband is missing or broken. see back label for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough 
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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:

  • skin reddening
  • blisters
  • rash

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 5 mg
  • store at 20-25˚C (68-77˚F). Do not refrigerate.
  • do not use if printed shrinkband is missing or broken.
  • see back label for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, FD & C blue no.1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN


DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 Volvo Parkway Chesapeake, VA 23320

MADE IN USA



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (240 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® COLD + MUCUS SEVERE*                             
FAMILY
wellnessTM

SEVERE COLD + MUCUS                      
Acetaminophen
- Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
Guaifenesin - Expectorant

For Adults

  • Headache
  • Body Ache
  • Cough
  • Fever
  • Sore Throat
  • Nasal Congestion
  • Mucus
  • Chest Congestion

8 FL OZ (240 mL) 
Daytime

Alcohol 0.5%
COOL BLAST
OTC
network



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (240 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (240 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-99355319-993-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ddc4d33d-9d9f-48c0-9dc8-66c2aa26b75de4a09f60-c586-4e5f-a48b-4613b98d0c702020-11-19WarningsExact identifier
spl id: ddc4d33d-9d9f-48c0-9dc8-66c2aa26b75d
spl set id: e4a09f60-c586-4e5f-a48b-4613b98d0c70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.