NDC | 70000-0161-1 |
Set ID | 80d25e23-b108-4eb1-88c7-73fe9da8f942 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cardinal Health 110, LLC. DBA Leader |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
LEADER™
NDC 70000-0161-1
Maximum Strength
Sinus Pressure + Pain
Acetaminophen | Pain Reliever / Fever Reducer
Phenylephrine HCl | Nasal DecongestantNon-Drowsy
Relieves:
Sinus Headache, Sinus Pressure,
Nasal Congestion24 CAPLETS
Actual Size
COMPARE TO
SUDAFED PE® SINUS
PRESSURE + PAIN
active ingredients*100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERINGCIN 5294335 REV. 3/21
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Sudafed PE® Sinus
Pressure + Pain 50844 REV0820B50208CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017www.myleader.com 1-800-200-6313
Essential to Care™ since 1979©2021 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
ESSENTIAL TO CARE, LEADER, and the Leader LOGO
are trademarks or registered trademarks of
Cardinal Health. All other marks are property
of their respective owners.100% Money Back Guarantee
Return to place of purchase if not satisfied.Leader 44-502
-
INGREDIENTS AND APPEARANCE
SINUS PRESSURE AND PAIN MAXIMUM STRENGTH
acetaminophen, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0161 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape OVAL Size 18mm Flavor Imprint Code 44;502 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0161-1 2 in 1 CARTON 06/23/2005 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 06/23/2005 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0161) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(70000-0161)