FDA.reportPublic FDA data

careone day cold and flu night cold and flu

Manufacturer
American Sales Company
Effective date
2019-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:17:47

Label at a glance#

Productcareone day cold and flu night cold and flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure13 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • sinus congestion and pressure • cough • minor aches and pains • headache • nasal congestion • sore throat • runny nose (NIGHT only) • sneezing (NIGHT only) • itching of the nose or throat (NIGHT only) • itchy, watery eyes due to hay fever (NIGHT only) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of botherso...

Dosage and administration

• do not take more than directed (see Overdose warning) • do not take more than 10 liquid gels in any 24-hour period • adults and children 12 years of age and older: take 2 liquid gels every 4 hours • children under 12 years of age: do not use

Storage and handling

• store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each liquid gel) DAY Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes DAY Cold Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each liquid gel) NIGHT Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes NIGHT Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • sinus congestion and pressure
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose (NIGHT only)
  • sneezing (NIGHT only)
  • itching of the nose or throat (NIGHT only)
  • itchy, watery eyes due to hay fever (NIGHT only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • controls cough to help you get to sleep
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: These products contain 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 these products

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 these products.
  • if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
  • taking sedatives or tranquilizers (NIGHT only)

When using these products

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT only)
  • marked drowsiness may occur (NIGHT only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
  • avoid alcoholic drinks (NIGHT only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT only)

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). Quick 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)
  • do not take more than 10 liquid gels in any 24-hour period
  • adults and children 12 years of age and older: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients (DAY only)

INACTIVE INGREDIENT SECTION

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

*may contain this ingredient

Inactive ingredients (NIGHT only)

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMBINATION PACK

Compare to the active ingredients in Mucinex® Fast-Max® Day Cold & Flu

DAY COLD & FLU

Pain Reliever/Fever Reducer – Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Expectorant – Guaifenesin

Nasal Decongestant – Phenylephrine HCl

Maximum Strength

Sore Throat, Fever, Chest Congestion, Cough, Nasal Congestion, Sinus Congestion, Sinus Pressure, Headache, Body Pain

Fast Dissolving Liquid Gels

For Ages 12+

Gluten Free

Actual Size

OUR PHARMACISTS RECOMMEND

16 LIQUID GELS (Liquid Filled Capsules)

Compare to the active ingredients in Mucinex® Fast-Max® Night Cold & Flu

NIGHT COLD & FLU

Pain Reliever/Fever Reducer – Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Antihistamine – Doxylamine Succinate

Nasal Decongestant – Phenylephrine HCl

Maximum Strength

Sore Throat, Fever, Itchy Throat, Cough, Nasal Congestion, Sneezing, Runny Nose, Headache, Body Pain

Fast Dissolving Liquid Gels

For Ages 12+

Gluten Free

Actual Size

OUR PHARMACISTS RECOMMEND

8 LIQUID GELS (Liquid Filled Capsules)

day cold and flu night cold and flu image 1
day cold and flu night cold and flu image 1
day cold and flu night cold and flu image 2
day cold and flu night cold and flu image 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-820-902024-05-06C16284748780-1f386c649-9a0d-0266-e053-dadaa90a7c1aAmerican Sales Company Day Cold & Flu Night Cold & Flu Drug Facts
41520-820-902023-01-30C16284748780-1f386c649-9a0d-0266-e053-dadaa90a7c1aAmerican Sales Company Day Cold & Flu Night Cold & Flu Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-82041520-820-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
0f1af30d-5882-41e8-b677-71a0b33d72a8d271848e-6945-4040-8ba3-560d1f7f7c2d2023-10-23WarningsExact identifier
spl set id: d271848e-6945-4040-8ba3-560d1f7f7c2d

Reported adverse events (FAERS/openFDA)#

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