Label: SEVERE SINUS CONGESTION AND PAIN MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
- NDC Code(s): 21130-615-09
- Packager: Better Living Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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 of acetaminophen in 24 hours
- 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
COMPARE TO
Maximum Strength Mucinex® SINUS-MAX® Severe
Congestion & Pain Active Ingredients*NDC 21130-615-09
Signature
Select™Severe Sinus
Congestion & PainMaximum Strength
Acetaminophen Pain Reliever
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant
• Relieves headache
• Thins and loosens mucus
• Relieves sinus congestionACTUAL SIZE
20 FILM COATED
ORANGE CAPLETS*This product is not manufactured or distributed by RB Health (US) LLC,
distributors of Maximum Strength Mucinex® SINUS-MAX® Severe
Congestion & Pain. 50844 REV0623A61509DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
1-888-723-3929TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGOUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.Signature Select 44-615
-
INGREDIENTS AND APPEARANCE
SEVERE SINUS CONGESTION AND PAIN MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-615 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) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:21130-615-09 2 in 1 CARTON 06/30/2013 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 Drug M012 06/30/2013 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(21130-615) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(21130-615) , pack(21130-615) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(21130-615) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(21130-615) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(21130-615)