Unishield Cold Relief by Unishield / Unifirst First Aid Corporation Unishield Cold Relief
Unishield Cold Relief by
Drug Labeling and Warnings
Unishield Cold Relief by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
UNISHIELD COLD RELIEF- phenylephrine hcl tablet
Unishield
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Unishield Cold Relief
Active ingredients (in each tablet)
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 15 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
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
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.
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
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
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.
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
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 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 ingredients
maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid.
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
| UNISHIELD COLD RELIEF
phenylephrine hcl tablet |
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| Labeler - Unishield (790677053) |
| Registrant - Unifirst First Aid Corporation (832947092) |
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