Daytime Cough

Manufacturer
KINGSTON PHARMA LLC
Effective date
2019-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:27

Label at a glance#

ProductDaytime Cough
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Other information Store between 20-25 degree Celsius (68-77 degree Fahrenheit) Each tablespoon contains: Sodium 50mg

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose: Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves these common cold/flu symptoms
    1. Minor aches and pains
    2. Headache
    3. Sore throat
    4. Nasal congestion
    5. Fever
    6. Cough due to minor throat and bronchial irritation

WARNINGS SECTION

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.

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.

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.
  • If you have ever had an allergic reaction to this product or any of its ingredients.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • Taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product

  • Do not exceed recommended dosage (see overdose warning)

Stop use and ask doctor if

  • Nervousness, dizziness or sleeplessness occur
  • 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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.
Overdose Warning: In case of accidental overdose, seek professional assistance or contact a Poison control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed. (see overdose warning)
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 4 hours.
  • Children 6 to under 12 years: take 1 tablespoon (TBSP) or 15 mL every 4 hours.
  • Children 4 to under 6 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

STORAGE AND HANDLING SECTION

Other information

  • Store between 20-25 degree Celsius (68-77 degree Fahrenheit)
  • Each tablespoon contains: Sodium 50mg

INACTIVE INGREDIENT SECTION

Inactive ingredients: Butylated hydroxyanisole, Edetate disodium, FD&C yellow 6, flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sucrose, Xanthan gum and Purified Water.

HOW SUPPLIED SECTION

(packs: 4oz) Kingston NDC# 71027-040-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
Label 2
Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN2
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD2
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY2
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY2
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-040-062020-09-27C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough
71027-040-062020-09-25C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough
71027-040-062020-07-22C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-040-06Daytime Cough1 in 1 CARTONLIQUID12
71027-040-06Daytime Cough177 mL in 1 BOTTLELIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-040DAYTIME COUGH LIQUID [KINGSTON PHARMA LLC]2Legacy NDC, 2 package rows20190206_5f7ad8db-c9f9-4462-99a7-eee24bd0cb62.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71027-04071027-040-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
a2ed7897-3b8f-4ec9-8def-fb8bb6641c5a5f7ad8db-c9f9-4462-99a7-eee24bd0cb622019-01-30WarningsExact identifier
spl id: a2ed7897-3b8f-4ec9-8def-fb8bb6641c5a
spl set id: 5f7ad8db-c9f9-4462-99a7-eee24bd0cb62

Reported adverse events (FAERS/openFDA)#

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