NEXT Severe Cold, Flu and Sore Throate Night Max Strength

Manufacturer
Genomma Lab USA Inc | Aurohealth LLC
Effective date
2019-12-03
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:55:55

Label at a glance#

ProductNEXT Severe Cold, Flu and Sore Throate Night Max Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure  cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat runny nose & sneezing promotes nasal and/or sinus drainage

Dosage and administration

take only as directed – see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Storage and handling

each 30 mL dose cup contains:  sodium 95 mg store at 20° to 25°C (68° to 77°F) keep carton for future reference

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 30 mL dose cup)


Acetaminophen USP 650 mg
Dextromethorphan HBr USP 20 mg
Doxylamine succinate USP 12.5 mg
Phenylephrine HCl USP 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure 
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • promotes nasal and/or sinus drainage

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.
  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • 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: Taking more than directed can cause serious health problems. 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

  • take only as directed – see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 TBSP) every 4 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 95 mg
  • store at 20° to 25°C (68° to 77°F)
  • keep carton for future reference

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, FD&C Blue no. 1, FD&C Red no. 40, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

call 1 877 99 GENOM (43666) (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:
Genoma Laba USA Inc.,
Houston, TX 77027

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (177 mL Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

NEXT

Night

Severe
Cold, Flu &
Sore Throat
 

  • Fever, Aches & Pains
  • Runny Nose, Nasal Congestion & Sinus Pressure
  • Cough

Acetaminophen

Pain Reliever - Fever Reducer
Dextromethorphan HBr 
Cough suppressant
Doxylamine succinate Antihistamine
Phenylephrine HCl Nasal decongestant

Berry Flavor                           

6 FL OZ (177 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (177 mL Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (177 mL Carton Label)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-92650066-926-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML · Source PDF

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
90cf3e88-8c40-4ea2-81db-e18ddaa6296fe15aad30-a2ad-44ff-ba2c-32da514c3e112020-11-26WarningsExact identifier
spl set id: e15aad30-a2ad-44ff-ba2c-32da514c3e11

Reported adverse events (FAERS/openFDA)#

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