NDC | 70000-0314-1 |
Set ID | 58fe81f8-3dc7-421a-bec4-3eb7f0548757 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cardinal Health |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- minor aches and pains
- headache
- nasal congestion
- sinus congestion and pressure
- 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 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 in 24 hours, which is the maximum daily amount
- 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
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- Directions
- Other information
-
Inactive ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
- Questions or comments?
-
Principal display panel
LEADER™
NDC 70000-0314-1
Daytime | Non-Drowsy
Sinus and Headache
Acetaminophen | Phenylephrine HCl
Pain Reliever / Fever Reducer | Nasal DecongestantNasal Congestion
Sinus Headache and PressureFor Adults
Pseudoephedrine-FreeCOMPARE TO TYLENOL®
SINUS + HEADACHE DAY
active ingredients*100% Money Back Guarantee
24 CAPLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark TYLENOL® SINUS + HEADACHE
DAY. 50844 ORG031646608CardinalHealth™
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979CARDINAL HEALTH, the Cardinal Health
LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of
Cardinal Health.100%
Money Back
Guarantee
Return to place of purchase.Leader 44-466C
-
INGREDIENTS AND APPEARANCE
SINUS AND HEADACHE DAYTIME, NON-DROWSY
acetaminophen, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0314 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color GREEN Score no score Shape OVAL Size 17mm Flavor MINT Imprint Code 44;466 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0314-1 2 in 1 CARTON 07/26/2005 04/10/2022 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 07/26/2005 04/10/2022 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(70000-0314) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(70000-0314)