DayTime Cold and Flu

Manufacturer
Mckesson | Velocity Pharma
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:10

Label at a glance#

ProductDayTime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

pain reliever, cough suppressant and Nasal decongestant

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

pain reliever

Cough Suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

pain reliever, cough suppressant and Nasal decongestant

Warnings

WARNINGS SECTION

Warnings Failure to follow these warnings could result in serious consequences.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

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

do not use:

  • with any other drug containing acetaminophen (prescription or not prescription). 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.

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
  • ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

  • Stop use and ask a doctor if:

  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • Children under 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions or Comments

OTC - QUESTIONS SECTION

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3fc61a23-figure-013fc61a23-figure-01

NDC: 70677-0011-1   24 liquid caps

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1

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
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-0011-12020-01-31C16284748780-19d75b9d1-1f50-f424-e053-dadaa90a57ceAcetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0011-1DayTime Cold and Flu24 in 1 BLISTER PACKCAPSULE, LIQUID FILLED241
70677-0011-1DayTime Cold and Flu1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0011DAYTIME COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE) CAPSULE, LIQUID FILLED [MCKESSON]1Legacy NDC, 2 package rows20161213_c13ccf97-76eb-4180-bd91-e4d7686f8b15.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-001170677-0011-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
3fc61a23-87f4-430f-8d08-62e288119c45c13ccf97-76eb-4180-bd91-e4d7686f8b152016-12-12WarningsExact identifier
spl id: 3fc61a23-87f4-430f-8d08-62e288119c45
spl set id: c13ccf97-76eb-4180-bd91-e4d7686f8b15

Reported adverse events (FAERS/openFDA)#

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