Label: CVS SEVERE CONGESTION AND PAIN RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
- NDC Code(s): 69842-717-06
- Packager: CVS
- 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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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- temporarily relieves:
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- nasal congestion
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- headache
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- minor aches and pains
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- sinus congestion and pressure
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- temporarily promotes nasal and/or sinus drainage
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- helps loosens 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
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.
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.
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 headache that lasts. These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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 - 180 mL Bottle Label
Compare to the active ingredients Maximum Strength* Mucinex®Sinus-Max® Severe Congestion & Pain**
NDC 63824-261-66
ADULT
Severe CongestionPain Reliever
Acetaminophen – Pain Reliever
GUAIFENESIN – Expectorant
PHENYLEPHRINE HCl – Nasal DecongestantMAXIMUM STRENGTH*
Multi-Symptom
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- Clears Sinus Congestion
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- Relieves Headache
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- Thins & Loosens Mucus
For Ages 12 Years & Over
6 FL OZ (180mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
*Per 4- hour dose
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02985
© 2020 CVS/pharmacy
CVS.com
1-800-SHOP CVS
V-12431
*This product is not manufactured or distributed by RB Health, the distributor of Maximum Strength* Mucinex® Sinus-Max® Severe Congestion & Pain.
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INGREDIENTS AND APPEARANCE
CVS SEVERE CONGESTION AND PAIN RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-717 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 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) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-717-06 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/30/2020 Labeler - CVS (062312574)
