Daytime Cold and Flu Liquid Gels

Manufacturer
Ocean Healthcare Private Limited | Sidharth Baid
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:19:46

Label at a glance#

ProductNighttime Cold and Flu Liquid Gels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure22 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each LiquiCap) - Purpose

Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Phenylephrine HCl 5 mg -Nasal decongestant

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Liver disease
  • Heart disease
  • Thyroid disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

OTC - DO NOT USE SECTION

Do not use

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - PURPOSE SECTION

Active Ingredient-Purpose

Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Phenylephrine HCl 5 mg -Nasal decongestant

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • You get nervous, dizzy or sleepless
  • Symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each LiquiCap) - Purpose

Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 15 mg -Cough suppressant

Doxylamine succinate 6.25 mg -Antihistamine

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Liver disease
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - DO NOT USE SECTION

Do not use

  • Wth 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - PURPOSE SECTION

Active ingredients (in each LiquiCap) -Purpose
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 15 mg -Cough suppressant
Doxylamine succinate 6.25 mg -Antihistamine

OTC - QUESTIONS SECTION

Questions

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Pain 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.

OTC - WHEN USING SECTION

When using this product

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, & tranquilizers may increase drowsiness

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box LabelBox Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Cold and Flu Liquid GelsNighttime Cold and Flu Liquid Gels

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73751-00373751-003-01
73751-00973751-009-01

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#

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
0b44d519-39f2-614d-e063-6294a90ab9b09fc1d877-1e74-c85e-e053-2995a90acc062023-11-29Exact identifier
spl id: 0b44d519-39f2-614d-e063-6294a90ab9b0
spl set id: 9fc1d877-1e74-c85e-e053-2995a90acc06

Reported adverse events (FAERS/openFDA)#

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