Label: SINUS PRESSURE AND PAIN PE MAXIMUM STRENGTH- acetaminophen and phenylephrine hcl tablet
- NDC Code(s): 11822-5022-8
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 19, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
NDC 11822-5022-8
Compare to the active ingredients in
Sudafed PE® Pressure + Pain*MAXIMUM STRENGTH
SINUS PRESSURE &
PAIN RELIEF PEACETAMINOPHEN 325 mg
PAIN RELIEVER / FEVER REDUCER
PHENYLEPHRINE HCI 5 mg
NASAL DECONGESTANTNON-DROWSY
Relieves sinus headache, sinus pressure & congestion
ACTUAL SIZE
24
CAPLETSTAMPER 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 Kenvue Inc., owner of the
registered trademark SUDAFED PE® SINUS PRESSURE + PAIN.
50844 REV0820F50208DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.comSATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.Rite Aid 44-502
-
INGREDIENTS AND APPEARANCE
SINUS PRESSURE AND PAIN PE MAXIMUM STRENGTH
acetaminophen and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5022 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, UNSPECIFIED (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 (light orange / peach) 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:11822-5022-8 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 Drug M012 06/23/2005 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-5022) , pack(11822-5022) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-5022)