Label: COLD FLU AND SORE THROAT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 0363-1209-30
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 9, 2019
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
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Uses
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- temporarily relieves these common cold and flu symptoms:
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- cough
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- nasal congestion
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- minor aches and pains
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- sore throat
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- headache
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- temporarily reduces fever
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- temporarily promotes nasal and/or sinus drainage
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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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- if you have ever had an allergic reaction to this product or any of its ingredients
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if
- When using
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Stop use and ask a doctor if
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- nervousness, dizziness or sleeplessness occur
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- pain, nasal congestion, or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- do not take more than directed (see Overdose warning)
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- do not take more than 5 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Mucinex® Fast-Max® Cold, Flu & Sore Throat active ingredients
MUCUS RELIEF
Cold, Flu & Sore Throat
ACETAMINOPHEN /
PAIN RELIEVER & FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
MAXIMUM STRENGTH
Relieves headache, fever, sore throat, nasal & chest congestion
Thins & loosens mucus
Controls cough
12 years & older
6 FL OZ (180 mL)
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INGREDIENTS AND APPEARANCE
COLD FLU AND SORE THROAT
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1209 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1209-30 1 in 1 CARTON 08/04/2018 1 180 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/04/2018 Labeler - Walgreen Company (008965063)
