CONTAC

Manufacturer
Vespyr Brands, Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:52

Label at a glance#

ProductCONTAC Cold Flu Day Night
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure18 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: • nasal congestion • headache • minor aches and pains • stuffy nose • sore throat • fever • sinus congestion and pressure

Dosage and administration

• do not take more than directed (see overdose warning). • adults and children 12 yrs of age and over: take 2 caplets every 6 hrs as needed. • do not take more than 8 caplets in 24 hrs. • children under 12 yrs of age: ask a doctor.

Storage and handling

store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients(in each caplet) (Day)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg

Purposes (Day)

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Nasal decongestant

Uses (Day)

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:
• nasal congestion • headache
• minor aches and pains • stuffy nose
• sore throat • fever
• sinus congestion and pressure

Warnings (Day)

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4000 mg of acetaminophen in 24 hrs, which is the maximum daily amount
• 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, ask 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• liver disease • heart disease
• diabetes • high blood pressure
• thyroid • trouble urinating due to disease an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• you get nervous, dizzy, or sleepless
• new symptoms occur

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick
medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (Day)

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed (see overdose warning).
• adults and children 12 yrs of age and over: take 2 caplets every 6 hrs as needed.
• do not take more than 8 caplets in 24 hrs.
• children under 12 yrs of age: ask a doctor.

Other information (Day)

STORAGE AND HANDLING SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients (Day)

INACTIVE INGREDIENT SECTION

corn starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.

Questions or comments? (Day)

OTC - QUESTIONS SECTION

call toll-free 1-855-874-0970 (English/Spanish) weekdays

Active ingredients (in each caplet) (Night)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg

Purposes (Night)

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses (Night)

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:
• nasal congestion • sneezing • headache
• runny nose • fever • sore throat
• minor aches and pains

Warnings (Night)

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount
• 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, ask 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• liver disease • heart disease
• diabetes • high blood pressure
• thyroid disease • glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product
• do not exceed recommended dosage
• drowsiness may occur • avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness effect
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• you get nervous, dizzy, or sleepless • new symptoms occur
These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (Night)

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed (see overdose warning).
• adults and children 12 years of age and over: take 2 caplets every 6 hours as needed.
• do not take more than 8 caplets in 24 hours.
• children under 12 years of age: ask a doctor.

Other information (Night)

STORAGE AND HANDLING SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients (Night)

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions or comments? (Night)

OTC - QUESTIONS SECTION

call toll-free 1-855-874-0970 (English/Spanish) M - F, 8am -5pm EST

SPL UNCLASSIFIED SECTION

NDC 71179-025-28

CONTAC ®

COLD + FLU

DAY

Acetaminophen -

Pain reliever/Fever reducer

Phenylephrine hydrochloride -

Nasal decongestant

Head & Body Aches

Fever • Sore Throat

Nasal Congestion

Sinus Pressure

16 CAPLETS

NIGHT

Acetaminophen -

Pain reliever/Fever reducer

Chlorpheniramine maleate -

Antihistamine

Phenylephrine hydrochloride -

Nasal decongestant

Head & Body Aches

Fever • Sore Throat

Nasal Congestion

Sinus Pressure

Runny Nose • Sneezing

12 CAPLETS

Maximum Strength

Multi-Symptom

DISTRIBUTED BY:

Vespyr Brands ®, Inc.

East Windsor NJ 08520

©2022 Vespyr Brands ®, Inc.

All rights reserved

CONTAC ® is a registered trademark of Vespyr Brands ®, Inc.

www.contac.com

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101555{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCK1
11015551 daytime (acetaminophen 500 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSN1
1052679acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1052679acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
11015551 daytime (acetaminophen 500 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet) PackSY1
1052679APAP 500 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71179-025-28CONTACCold Flu Day Night1 in 1 BOXKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71179-025CONTAC COLD FLU DAY NIGHT (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE) KIT [VESPYR BRANDS, INC.]11 package rows20240110_0cdd028b-8f08-2351-e063-6394a90aa0ef.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71179-02571179-025-28
71179-024
71179-026

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
5a88752d-aab1-de28-e063-6394a90ae9440cdd028b-8f08-2351-e063-6394a90aa0ef2026-09-02WarningsExact identifier
spl set id: 0cdd028b-8f08-2351-e063-6394a90aa0ef

Reported adverse events (FAERS/openFDA)#

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