Label: UNISHIELD COUGH AND COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin tablet, film coated
- NDC Code(s): 49314-4358-0
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
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
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.
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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 product. -
ASK DOCTOR
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
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
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
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INGREDIENTS AND APPEARANCE
UNISHIELD COUGH AND COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-4358 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color orange Score no score Shape CAPSULE (caplet) Size 17mm Flavor Imprint Code 44;546 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-4358-0 40 in 1 BOX 09/26/2022 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/26/2022 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)