Daytime Fast Severe Cold Relief Nitetime Fast Cold and Flu Relief

Manufacturer
Kroger Company
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:44:19

Label at a glance#

ProductDaytime Fast Severe Cold Relief Nitetime Fast Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure19 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • cough • minor aches and pains • headache • nasal congestion • sore throat • runny nose and sneezing (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 (NIGHT only) • temporarily reduces fever

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 Severe Cold

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes – DAY Severe Cold

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:
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose and sneezing (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 (NIGHT only)
  • 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

1-800-632-6900

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredients of MUCINEX® FAST-MAX® DAY SEVERE COLD & NIGHT COLD & FLU

See side panel

DAYTIME

FAST

Severe Cold Relief

MAXIMUM STRENGTH

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr,

Cough Suppressant

Guaifenesin, Expectorant

Phenylephrine HCl, Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

Our Pharmacists Recommend

16 FAST

DISSOLVING

LIQUID GELS

(liquid filled capsules)

actual size

NITETIME

FAST

Cold & Flu

Relief

MAXIMUM STRENGTH

Acetaminophen,

Pain Reliever/Fever Reducer

Dextromethorphan HBr,

Cough Suppressant

Doxylamine Succinate, Antihistamine

Phenylephrine HCl, Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal Congestion

Relieves Runny Nose & Sneezing

Our Pharmacists Recommend

8 FAST

DISSOLVING

LIQUID GELS

(liquid filled capsules)

actual size

Daytime Fast Severe Cold Relief Nitetime Fast Cold & Flu Relief Carton Image 2
Daytime Fast Severe Cold Relief Nitetime Fast Cold & Flu Relief Carton Image 2
Daytime Fast Severe Cold Relief Nitetime Fast Cold & Flu Relief Carton Image 1
Daytime Fast Severe Cold Relief Nitetime Fast Cold & Flu Relief Carton Image 1

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-81130142-811-90
30142-50630142-506-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a0fd652b-108f-4f9a-b7b0-4fb4a4b36bc5a558faec-784f-4287-9673-f32ea9a65eff2020-12-03WarningsExact identifier
spl set id: a558faec-784f-4287-9673-f32ea9a65eff

Reported adverse events (FAERS/openFDA)#

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