Label: SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hcl tablet
- NDC Code(s): 49035-558-22, 49035-558-42
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 25, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each gelcap)
- Purpose
-
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- 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
- heart disease
- diabetes
- liver disease
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- 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 49035-558-22
equate™
Compare to
Tylenol® SINUS
+ HEADACHE
Day Active
Ingredients*Rapid Release
Sinus
Congestion
& Pain
Acetaminophen, Phenylephrine HCl
Pain Reliever, Fever Reducer, Nasal DecongestantDaytime Non-Drowsy
• Sinus headache & pressure
• Nasal congestion48 GELCAPS
Actual Size
TAMPER EVIDENT:
DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS
TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERINGSatisfaction guaranteed -
Or we'll replace it or give you your
money back.
For questions or comments,
please call 1-888-287-1915.DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716*This product is not manufactured or
distributed by Johnson & Johnson Corporation,
owner of the registered trademark Tylenol®
SINUS + HEADACHE Day.
50844 REV0418D55822
Equate 44-558
-
INGREDIENTS AND APPEARANCE
SINUS CONGESTION AND PAIN DAYTIME
acetaminophen and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-558 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) Product Characteristics Color red (red, green and gray in the middle) , 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:49035-558-22 4 in 1 CARTON 03/17/2008 12/31/2025 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49035-558-42 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/17/2008 12/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/17/2008 12/31/2025 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(49035-558) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(49035-558) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-558) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(49035-558) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(49035-558)