NDC | 66715-5744-2, 66715-5744-8 |
Set ID | 66170885-fff0-4953-a4ac-02eaad00d594 |
Category | HUMAN OTC DRUG LABEL |
Packager | Lil' Drug Store Products, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- 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)