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Allergy Plus Sinus Headache by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on September 16, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0464

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.

Assured 44-464

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STARCH, CORN 
CROSPOVIDONE, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;464
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0464-82 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:33992-0464-21 BLISTER PACK in 1 CARTON
212 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/2005
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0464)

 
GREENBRIER INTERNATIONAL, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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