Label: CIRCLE K MULTI-SYMPTOM SINUS RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
- NDC Code(s): 66715-5744-2, 66715-5744-3, 66715-5744-8
- Packager: Lil' Drug Store Products, Inc.
- 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 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- For the temporary relief of:
- sinus congestion and pressure
- nasal congestion
- headache
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies
- For the temporary relief of:
-
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:
- 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
- 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 is accompanied by a fever, rash or persistent headache
- nervousness, dizziness or sleeplessness occur.
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton
Compare to the Active Ingredients in
Tylenol® Sinus Severe †CIRCLE K ®
Multi-
SymptomSinus
severe
congestionAcetaminophen, Guaifenesin and Phenylephrine HCl
Pain Reliever, Expectorant, Nasal DecongestantNon-Drowsy Relief of
- Chest & Nasal Congestion
- Sinus Pressure
ACTUAL SIZE
4 Tablets
2 POUCHES, 2 TABLETS PER POUCH -
INGREDIENTS AND APPEARANCE
CIRCLE K MULTI-SYMPTOM SINUS RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5744 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) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) FD&C RED NO. 40 (UNII: WZB9127XOA) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape ROUND Size 12mm Flavor Imprint Code FR14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-5744-2 2 in 1 CARTON 12/30/2018 11/13/2023 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-5744-8 8 in 1 CARTON 12/30/2018 04/26/2024 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-5744-3 3 in 1 CARTON 10/15/2019 04/30/2024 3 2 in 1 POUCH; 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 12/07/2015 04/30/2024 Labeler - Lil' Drug Store Products, Inc. (093103646)