Label: SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-515-09 - Packager: CVS Pharmacy
- 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 April 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- with other drugs containing acetaminophen
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 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.
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 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.
- If you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- pain, nasal congestion, or cough gets worse or lasts more than 7 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
♥︎CVS
Health™Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief*
NDC 59779-515-09
MAXIMUM STRENGTH
Sinus Relief
Severe Congestion
ACETAMINOPHEN - Pain reliever
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCl - Nasal decongestantRelieves:
• Headache
• Nasal & Chest congestion
Thins & Loosens mucus20 CAPLETS Ages 12 Years & Over
Actual Size
*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief. 50844 REV0117A61509
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com 1-800-SHOP CVS
V-19849CVS® Quality
Money Back Guarantee
CVS 44-615
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INGREDIENTS AND APPEARANCE
SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-515 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;615 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-515-09 2 in 1 CARTON 06/30/2014 1 10 in 1 BLISTER PACK; 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 06/30/2014 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(59779-515) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(59779-515) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(59779-515) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(59779-515) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(59779-515)