Unishield Cold Relief

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2023-02-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:35:45

Label at a glance#

ProductUnishield Cold Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE SECTION

Temporarily relieves these cold symptoms

■ cough

■ sore throat

■ minor aches and pains

■ headache

■ nasal congestion

■ helps loosen phlegm (mucus) and thin bronchial secretions to 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 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, 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.

■ no more than 10 days unless directed by a doctor

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

■ 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 use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ new symptoms occur

■ redness or swelling is present

■ pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

■ you get nervous, dizzy or sleepless

■ 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
(1-800-222-1222). 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

Adults and children:

(12 years and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years

Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid.

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5855

Unishield Cold Relief Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold Relief

Multi-Symptom

100 Tablets/ 1 Tablet Per Packet

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Pull To Open

This package is for Households Without Young Children.

• Pain reliever/fever reducer

• Quiets coughs

• Loosens phlegm and thins broncial secretions

• Relieves sinus congestant

Relieves coughs, minor aches, headache, congestion & fever

Tamper Evident Unit Dose Packets

Compare active ingredients to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

425R425R

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
49314-425349314-4253-3

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

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
f55f4bc2-ee31-f3e3-e053-2a95a90a26e7b9cf8ec5-96b8-cad2-e053-2995a90a19912023-02-23WarningsExact identifier
spl id: f55f4bc2-ee31-f3e3-e053-2a95a90a26e7
spl set id: b9cf8ec5-96b8-cad2-e053-2995a90a1991

Reported adverse events (FAERS/openFDA)#

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