Label: SINUS CONGESTION AND PAIN RELIEF NON-DROWSY, DAYTIME- acetaminophen and phenylephrine hcl tablet, coated
- NDC Code(s): 11822-0588-4, 11822-0588-7, 11822-0588-8
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 19, 2024
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- Active ingredients (in each gelcap)
- Purpose
-
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- sinus congestion and pressure
- minor aches and pains
- nasal congestion
- 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 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
- liver disease
- thyroid disease
- heart disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
-
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide
- Questions or comments?
-
Principal Display Panel
NDC 11822-0588-8
Compare to the active ingredients in
Tylenol® SINUS + HEADACHE Day*DAYTIME SINUS
CONGESTION
& PAIN RELIEFACETAMINOPHEN 325 mg
PHENYLEPHRINE HCl 5 mgPAIN RELIEVER / FEVER REDUCER
NASAL DECONGESTANTDAYTIME • NON-DROWSY
Relieves headache, nasal congestion,
sinus congestion & pressureACTUAL SIZE
24
GELCAPSTAMPER 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 Tylenol® SINUS + HEADACHE Day.
50844 REV0422F55808DISTRIBUTED 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 44-558
-
INGREDIENTS AND APPEARANCE
SINUS CONGESTION AND PAIN RELIEF NON-DROWSY, DAYTIME
acetaminophen and phenylephrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0588 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red, green Score no score Shape OVAL Size 19mm Flavor Imprint Code L;8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0588-8 2 in 1 CARTON 03/17/2008 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-0588-7 1 in 1 CARTON 03/17/2008 11/20/2014 2 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:11822-0588-4 1 in 1 CARTON 03/17/2008 03/12/2023 3 2 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 03/17/2008 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(11822-0588) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-0588) , pack(11822-0588) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-0588) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-0588)