![COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]](https://medic.hrt.org//dailymed/images/f7abb68d-2a80-49ca-bda8-8d30ff8383b8/cvs-44-615-1.jpg)
| NDC | 59779-651-01, 59779-651-09 |
| Set ID | f7abb68d-2a80-49ca-bda8-8d30ff8383b8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CVS Pharmacy |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- fever
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold and flu symptoms:
-
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
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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
- difficulty in urination due to enlargement of the prostate gland
- diabetes
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- high blood pressure
- heart disease
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
♥︎CVS
Health™Compare to the active ingredients in Mucinex®*
Cold & Sinus
ACETAMINOPHEN - Pain reliever, Fever reducer
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCl - Nasal decongestantMAXIMUM STRENGTH
Relieves:
Pain, Sinus pressure
& Nasal congestionReduces fever
Thins & Loosens mucusFor Ages 12+
30 CAPLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Mucinex®.
50844 REV0917B61501Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-19849CVS® Quality
Money Back Guarantee
CVS 44-615
-
INGREDIENTS AND APPEARANCE
COLD AND SINUS MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-651 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) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 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:59779-651-01 3 in 1 PACKAGE 06/30/2013 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59779-651-09 2 in 1 PACKAGE 06/30/2013 08/21/2019 2 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 06/30/2013 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(59779-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(59779-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(59779-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(59779-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(59779-651)