Label: SINUS PE PRESSURE, PAIN AND MUCUS- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
- NDC Code(s): 21130-927-08
- Packager: Better Living Brands, LLC
- 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 July 22, 2023
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
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
-
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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- heart disease
- diabetes
- thyroid disease
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 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.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Signature™
careQuality Guaranteed
Compare to
Sudafed PE®
Pressure + Pain
+ Mucus
active ingredients*NDC 21130-927-08
Sinus PE
Pressure, Pain & MucusACETAMINOPHEN - Pain Reliever/Fever Reducer
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant• Non-drowsy
• Sinus pressure/congestion
• Sinus headache
• Chest congestionActual Size
24 CAPLETS
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark SUDAFED PE® PRESSURE + PAIN + MUCUS.
50844 REV0917B52708DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com
Signature Care 44-527C
-
INGREDIENTS AND APPEARANCE
SINUS PE PRESSURE, PAIN AND MUCUS
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-927 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 (UNII: 2S7830E561) 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) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor MENTHOL Imprint Code 44;527 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-927-08 2 in 1 CARTON 08/06/2005 02/09/2025 1 12 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 08/06/2005 02/09/2025 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(21130-927) , pack(21130-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(21130-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(21130-927)