NDC | 63868-984-24 |
Set ID | d19681b4-b3c0-43e6-9c5c-b626a202346b |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
- temporarily reduces fever
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
-
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
-
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over - take 2 caplets every 4 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
children under 12 years - ask a doctor
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL
NDC 63868-984-24
QUALITY CHOICE
†Compare to TYLENOL® Sinus Congestion & Pain Daytime active ingredients
Daytime, Non-Drowsy
Sinus Congestion & Pain
For Adults
Pain Reliever / Fever Reducer, Nasal Decongestant
Acetaminophen, Phenylephrine HCl
For Relief of:
Sinus Headache / Sinus Pressure
Nasal Congestion
24 Cool Taste Caplets
SEE NEW WARNINGS INFORMATION & DIRECTIONS
Non-Drowsy Daytime
-
INGREDIENTS AND APPEARANCE
SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-984 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 17mm Flavor MINT Imprint Code AAA;1114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-984-24 2 in 1 CARTON 08/29/2007 06/30/2022 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 08/29/2007 06/30/2022 Labeler - Chain Drug Marketing Association (011920774)