Unishield Cough and Cold

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:31

Label at a glance#

ProductUnishield Cough and Cold
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves these symptoms due to the common cold:
■ headache
■ nasal congestion
■ cough
■ minor aches and pains
■ sore throat
■ sinus congestion and pressure
■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Temporarily reduces fever.

WARNINGS SECTION

Warnings

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

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert:

Acetaminophen may cause a severe skin reactions. Symptoms may include:

■ blisters

■ rash

■ skin reddening

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, 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 have ever had an allergic reaction to this product or any of its ingredients
■ 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

■ high blood pressure

■ thyroid disease

■ diabetes

■ difficulty in urination due to enlargement of the prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

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

■ nervousness, dizziness, or sleeplessness occur

■ pain, cough or nasal congestion gets worse or lasts for 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 - 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. 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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets every 4 hours

■ not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5855

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unishield

Cough & Cold

Multi-Symptom

80 Caplets / 2 Caplets Per Packet

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pull To Open

This Package is for Households Without Young Children.

• Pain reliever/fever reducer

• Quiets coughs

• Losens phlem and thins bronchial secretions

• Relieves sinus congestion

Relieves coughs, minor aches, headache, congestions & fever

Tamper Evident Unit Dose Packets

Unishield 435RUnishield 435R

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-4358-0Unishield Cough and Cold2 in 1 PACKETTABLET, FILM COATED22
49314-4358-0Unishield Cough and Cold40 in 1 BOXTABLET, FILM COATED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49314-4358UNISHIELD COUGH AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN) TABLET, FILM COATED [UNISHIELD]2Legacy NDC, 2 package rows20240118_e6ff40aa-f5f9-a5bd-e053-2995a90adabd.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-435849314-4358-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
0f287d98-760d-eb61-e063-6294a90a2910e6ff40aa-f5f9-a5bd-e053-2995a90adabd2024-01-17WarningsExact identifier
spl id: 0f287d98-760d-eb61-e063-6294a90a2910
spl set id: e6ff40aa-f5f9-a5bd-e053-2995a90adabd

Reported adverse events (FAERS/openFDA)#

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