Label: MULTI-SYMPTOM COLD RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coated
- NDC Code(s): 47682-047-80, 47682-047-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2024
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- 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 cough more productive
Temporarily reduces fever.
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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 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.
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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.
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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 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
Multi-Symptom Cold Relief™
Pull to Open
Tire Para Abrir
Acetaminophen / Acetaminofeno 325 mg
Dextromethorphan HBr / Hidrobromuro de dextrometorfano 10 mg
Guaifenesin / Guaifenesina 100 mg
Phenylephrine HCl / Hidrocloruro de fenilefrina 5 mg
Green Guard®
Pain reliever/Fever reducer
Multi-Symptom Relief
Alivia el dolor/Reduce la fiebre
Alivia multisintomas
Distributed by Green Guard®
St Louis, MO 63045
40 Packets of 2 Caplets
80 Caplets
Order #2580
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INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM COLD RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-047 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CROSPOVIDONE (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) 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:47682-047-80 40 in 1 BOX 09/26/2022 1 NDC:47682-047-99 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 - Unifirst First Aid Corporation (832947092)