NDC | 59779-802-08 |
Set ID | a3b073b4-494c-4531-b08e-475c86ba321d |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
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
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- diabetes
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
CVS
Health®Compare to the active ingredients in SUDAFED PE® PRESSURE + PAIN*
Non-Drowsy
Sinus PE Pressure + Pain
ACETAMINOPHEN - Pain reliever, Fever reducer
PHENYLEPHRINE HYDROCHLORIDE - Nasal decongestantMAXIMUM STRENGTH
Relieves:
•Sinus pain & headache
•Sinus pressure
•Nasal & sinus congestion24 CAPLETS UNCOATED
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 SUDAFED PE® PRESSURE + PAIN.
50844 REV0820C50208Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy CVS.com®
1-800-SHOP CVSV-19849
CVS®Quality
Money Back GuaranteeCVS Health 44-502
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INGREDIENTS AND APPEARANCE
SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH
acetaminophen, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-802 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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) 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:59779-802-08 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 - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(59779-802) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(59779-802)