NEXT COLD and FLU

Manufacturer
Genomma Lab USA, Inc. | AptaPharma Inc.
Effective date
2017-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:38

Label at a glance#

ProductNEXT COLD and FLU DAYTIME
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever

Dosage and administration

take only as directed (see Warnings) do not exceed 4 doses per 24 hours Adults and children 12 years and over: take 2 softgels with water every 4 hours Children 4 to under 12 years: Ask a doctor Children under 4 years: Do not use When using Day Time ot Night Time products, carefully read each label to ensure correct dosing

Label contents#

Full prescribing information#

Drug FactsActive ingredients(in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCL 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

WARNINGS SECTION

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

  • more than 4 doses in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists 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 products 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 an MAOI drug. If you do not know if ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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 dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adult)
  • 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
  • a skin reaction occurs. 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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. 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

  • take only as directed (see Warnings)
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over:
    take 2 softgels with water every 4 hours
  • Children 4 to under 12 years: Ask a doctor

Children under 4 years: Do not use

  • When using Day Time ot Night Time products, carefully read each label to ensure correct dosing

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, D&C Yellow #6, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Call 1-877-99-Genom (43666)
Weekdays from 8am to 6 pm

NEXT COLD & FLU DAYTIME product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non Drowsy

NEXT
COLD & FLU

DAYTIME RELIEF

  • Fever
  • Cough
  • Sore Throat
  • Aches
  • Nasal Congestion

Acetaminophen/
Dextromethorphan HBr /Phenylephrine HCL

24 Softgels

Tamper evident: Do not use if blisters are torn or open

Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77027

Made in India

BX-055

AptaPharmGen Daytime 604AptaPharmGen Daytime 604

AptaPharmGen Daytime 604 blisterAptaPharmGen Daytime 604 blister

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-60450066-604-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
7b00de0c-2d39-44d5-9288-1845398fabac0b951fce-9172-461c-81bf-5afaa7953b252024-01-23WarningsExact identifier
spl set id: 0b951fce-9172-461c-81bf-5afaa7953b25

Reported adverse events (FAERS/openFDA)#

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