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Severe Allergy Relief Plus Sinus Headache

Medically reviewed on May 28, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GoodSense
NDC Code: 50804-473

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.

GDS - 1126 - 2016-0523

Drug Facts

Active ingredients
(in each caplet)
Purpose
Acetaminophen 325 mgPain reliever
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 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.
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged 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
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

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

Directions
  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not to take more than 12 caplets in 24 hours
children under 12 years
  • ask a doctor

Other information
  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

GoodSense
NDC 50804-473-02
Maximum Strength
Pain Reliever
Nasal Decongestant
Antihistamine
Severe Allergy Relief
Plus Sinus Headache
Acetaminophen
Phenylephrine HCl
Diphenhydramine HCl
• Sinus Headache
• Sinus Pressure & Congestion
• Runny Nose & Itchy Throat
• Itchy, Watery Eyes
• Sneezing
20 CAPLETS
Compare to active ingredients of Benadryl® Severe Allergy Plus Sinus Headache†
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SEVERE ALLERGY RELIEF PLUS SINUS HEADACHE 
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-473
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
COPOVIDONE K25-31 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
HYPROMELLOSES 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
POVIDONES 
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint CodeAAA;116
Contains    
Packaging
#Item CodePackage Description
1NDC:50804-473-022 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2011
Labeler - GoodSense (076059836)

 
GoodSense

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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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