Label: CVS MAXIMUM STRENGTH COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid
- NDC Code(s): 69842-566-06
- Packager: CVS PHARMACY, INC
- 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 September 14, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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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- sinus congestion and pressure
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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 6 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks daily while using this product
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
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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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- for children under 12 years of age
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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.
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough that occurs with too much phlegm (mucus)
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 persistent headache.
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- These could be signs of a serious condition.
- Overdose warning
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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 6 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 the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu
NDC 69842-566-06
Maximum Strength‡
Cold , Flu &
Sore Throat
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant- •
- Controls Cough, Thins & Loosens Mucus
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- Nasal & Chest Congestion
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- Sinus Pressure & Congestion
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- Body Pain, Headache, Fever & Sore Throat
For Ages 12+
6 FL OZ (180 mL)
Do not use if printed seal under cap is broken or missing.
‡ Per 4-hour dose.
Distributed by:
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength‡ Mucinex® Fast-Max® Cold, Flu & Sore Throat
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INGREDIENTS AND APPEARANCE
CVS MAXIMUM STRENGTH COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-566 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) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-566-06 180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/11/2022 Labeler - CVS PHARMACY, INC (062312574)
