The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each tablet) Acetaminophen 325 mgDextromethorphan Hydrobromide 15 mgGuaifenesin 200 mg Phenylephrine Hydrochloride 5 mg
Otc - Purpose
PurposePain reliever/ fever reducerCough suppressantExpectorantNasal decongestant
Indications & Usage
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 productiveTemporarily reduces fever.
WarningsLiver 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening■ blisters■ rashIf 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
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
■ no more than 10 days unless directed by a doctor
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are■ taking the blood thinning drug warfarin
Otc - When Using
When using this product■ do not use more than directed
Otc - Stop Use
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
DirectionsAdults 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 yearsAsk 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 ingredientsmaltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid.
Otc - Questions
Questions or comments? 800-480-5855
Unishield Cold Relief Label
Cold ReliefMulti-Symptom100 Tablets/ 1 Tablet Per PacketAcetaminophen 325 mgDextromethorphan HBr 15 mgGuaifenesin 200 mgPhenylephrine HCl 5 mgPull To OpenThis package is for Households Without Young Children.• Pain reliever/fever reducer• Quiets coughs• Loosens phlegm and thins broncial secretions• Relieves sinus congestantRelieves coughs, minor aches, headache, congestion & feverTamper Evident Unit Dose PacketsCompare active ingredients to:Sudafed PE®Registered Trademark of McNeil Consumer HealthcareTamper Evident Unit Dose Packets
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