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#
Contacts and useful links#
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
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
Products#
Every source-derived product name is available through these pages.
- Unishield Cold Relief
- Phenylephrine HCl
- ACETAMINOPHEN
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- MALTODEXTRIN
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- SILICON DIOXIDE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CELLULOSE, MICROCRYSTALLINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49314-4253 | 49314-4253-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f55f4bc2-ee31-f3e3-e053-2a95a90a26e7 | b9cf8ec5-96b8-cad2-e053-2995a90a1991 | 2023-02-23 | Warnings | f55f4bc2-ee31-f3e3-e053-2a95a90a26e7 b9cf8ec5-96b8-cad2-e053-2995a90a1991 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
