ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated 
GREENBRIER INTERNATIONAL, INC.

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Assured 44-464 Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses

  • temporarily relieves these symptoms of hay fever and the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes

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
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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.
  • with any other product containing diphenhydramine, even one used on skin
  • 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
  • glaucoma
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

MULTI-SYMPTOM
ALLERGY
PLUS SINUS HEADACHE
• Acetaminophen - Pain Reliever
• Diphenhydramine HCl - Antihistamine
• Phenylephrine HCl - Nasal Decongestant

Headache, Sneezing, Itchy & Watery Eyes,
Runny Nose, Itchy Throat,
Sinus Congestion & Pressure

Actual Size

12 caplets

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

50844    REV0517E46402

ITEM# 163821
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

Assured 44-464

Assured 44-464

ALLERGY PLUS SINUS HEADACHE 
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0464
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;464
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0464-21 in 1 CARTON06/15/200512/05/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:33992-0464-82 in 1 CARTON06/15/200512/05/2023
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/15/200512/05/2023
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(33992-0464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(33992-0464)

Revised: 10/2023
Document Id: 4b3a887a-e09e-47ee-a7ca-9c959d14553d
Set id: c7755456-517b-4542-a9ef-11ec89a20a16
Version: 15
Effective Time: 20231021
 
GREENBRIER INTERNATIONAL, INC.